UNKNOWN

ADAPTED_NOW

Preparation, review and approval of sampling matrix and hold time schedule Conducts and communicates results of lab investigations when test results fall outside pre-established specifications (OOS). Works collaboratively with other department stakeholders to ensure the services provided to the site are developed, tested, and delivered according to established procedures and regulations.

No Visa Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.POSITION SUMMARY:The Senior Microbiologist is a critical technical resource in the QC Microbiology laboratory supporting the manufacturing of sterile injectable products. This position is responsible for independently performing and overseeing complex microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA, and internal quality standards. This position is in a fast-paced, FDA regulated environment in the Pharmaceutical Industry.This role is mainly responsible for completing deviation investigations, OOS/OOT and CAPA development related to EM and microbiological testing. Maintains spreadsheets and databases to track and monitor department/company data, KPIs and metrics. Accountable for QC Microbiology inventory control including ordering materials, maintaining stock and resolving material complaints as needed. This role will serve as a Subject Matter Expert (SME) to provide guidance and support junior microbiologists. Train team members in aseptic technique, microbiological methods, EM sampling, and good documentation practices. Participate in the qualification of microbiology lab equipment. Identify and implement continuous improvement opportunities to optimize workflows in the quality control microbiology laboratory.OVERALL JOB RESPONSIBILITIES:Operational Excellence:<ul><li>Models the principles and behaviors of Glenmark and ensures personnel follow the company code of conduct.</li><li>Communicate progress, status, and roadblocks as required.</li><li>Drive projects, assignments, and complete presentations within timelines and budgets. Create and maintain relevant metrics for department/site.</li><li>Spreadsheets and databases will be leveraged for departmental and company metrics, presentations, and data/testing tracking/verification. The Senior Microbiologist is responsible for keeping these sheets and databases up to date.</li><li>Ability to perform routine testing of samples submitted to the laboratory as appropriate. Schedules and participates in cleaning, inventory, and maintenance tasks in the lab.</li><li>Supports inventory management and ordering/stocking of all QC department laboratory supplies.</li><li>Ensures laboratory equipment is in compliance with procedures and GLP requirements.</li><li>Troubleshoots laboratory issues related to all instrumentation. Recommends potential corrective and/or preventive actions and implements these actions within the laboratory.</li><li>Performs GMP review of test data to ensure that test results meet all specifications. Trends data and analyzes trends to proactively mitigate equipment and reagent performance issues. Verifies laboratory equipment and associated equipment logs to ensure proper operation</li></ul>Stakeholder:<ul><li>Preparation, review and approval of sampling matrix and hold time schedule Conducts and communicates results of lab investigations when test results fall outside pre-established specifications (OOS).</li><li>Performs routine equipment maintenance.</li><li>Performs maintenance of spare parts inventory, calibrations and supervises third party maintenance and repair when necessary.</li><li>Establishes good working relation with contract laboratories.</li><li>Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ/PQ protocols.</li><li>Supports activities regarding audits of suppliers and contract labs in support of vendor certification program.</li><li>Conducts statistical evaluation of the manufacturing and inspection process and training QC staff.</li><li>Ensure that all equipment is calibrated.</li><li>Responsible to develop and validate new test procedures</li><li>Perform data analysis, compile data and generate reports for management review.</li><li>Review lab test data and their integrity and adherence to SOPs and cGMP.</li></ul>Compliance:<ul><li>Maintain current knowledge of regulatory and industry standards, trends and advancements.</li><li>Responsible for ensuring compliance to systems and procedures in the EM/Microbiology laboratory and cleanroom areas. And prepare the lab for internal and external audits.</li><li>Support Continuous Improvement initiatives by providing support on updating SOPs, WIs, and OJT</li><li>Complete and maintain certified investigator training requirements. Perform investigation of the quality events assigned using root cause analysis tools, maintain timelines for closure of investigations and identify/initiate CAPAs</li><li>Complete and maintain status as a certified trainer</li><li>Ensure Quality Systems are compliant with cGMPs and internal/external regulations and procedures</li><li>Evaluates and assists in the implementation of new changes at the site, including providing training on an as needed basis</li><li>Provide support to collect and prepare EMPQ reports, EM Trend reports, QMR board presentations with associated documentation.</li><li>Performs regular self-audits of the Microbiology and EM laboratory areas (including storage areas) and assists/leads activities to address audit findings.</li></ul>Stakeholder:<ul><li>Works collaboratively with other department stakeholders to ensure the services provided to the site are developed, tested, and delivered according to established procedures and regulations.</li></ul>Innovation:<ul><li>Supports purchasing QC EM laboratory supplies. Makes sound, well considered decisions to make the most of available funds and resources. Monitors lab supply costs and looks for ways to work with suppliers to reduce consumables cost when appropriate.</li><li>Consults with management, when appropriate, about laboratory supply variances. Demonstrates the ability to assess upcoming laboratory supply needs and prepare accordingly. Makes realistic and actionable plans to address supply chain issues.</li><li>Maintains the QC department ordering system to reduce costs and waste due to expiry. Keeps current on physical and computerized tracking systems for materials and supplies.</li></ul>Safety:<ul><li>Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties</li></ul><ul></ul>KNOWLEDGE, SKILLS AND ABILITIES:Education:<ul><li>Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology</li></ul>Experience:<ul><li>Minimum of 3+ years in a pharmaceutical environment</li><li>Strong organizational skills. Displays the ability to prioritize work and manage multiple tasks independently.</li><li>Excellent written communication and technical writing skills. Clearly demonstrates competence in the selection and use of root cause analysis tools and techniques (e.g., 5 Whys, Pareto Analysis, 5M +E).</li><li>Displays strong interpersonal skills and ability to work with all levels of an organization. Clearly expresses ideas (verbal and written) and demonstrates the ability to apply a quality mindset when completing Microbiology/EM laboratory tasks.</li><li>Demonstrates the ability to read, understand, author, redline and execute standard operating procedures (SOPs).</li><li>Displays ability to achieve Glenmark Monroe QE investigator certifications for product/process/testing/facility issues with product and non-product impact.</li><li>Exhibits both analytical and problem-solving skills. Proven ability to problem solve/troubleshoot and provide solutions for laboratory issues.</li><li>Able to assess safety and environmental risks to ensure laboratory tasks adhere to EHS management system.</li><li>The ability to work independently and within team structure and on multiple projects, with flexibility to adapt to changing priorities is required. This candidate must be a technical expert and have excellent written and oral communication as well as interpersonal relationship skills.</li></ul>Ability to lift 30 lbs.’ and work within different extreme temperature / humidity environments as encountered in the various Incubator conditions.

Glenmark Pharmaceuticals Inc.

Senior Microbiology Analyst

Analysis Skills

Asepsis

Biology

Biotech and Pharmaceutical

Budgeting

Chemistry

Cleanroom

Communication Skills

Consulting

Continuous Improvement

Corrective Action

Corrective and Preventative Action (CAPA) Systems

Cost Control

Current Good Manufacturing Practice (cGMP)

Data Analysis

Data Collection

Database Administration

Documentation

Environmental Impact

Environmental Monitoring

Equipment Maintenance/Repair

Establish Priorities

External Audit

FDA (Food and Drug Administration)

GLP (Good Laboratory Practices)

GMP (Good Manufacturing Practices)

Housekeeping/Cleaning

Identify Issues

Industry Standards

Industry/Trade Analysis

Instrumentation

Internal Audit

Interpersonal Skills

Inventory Management

Laboratory

Laboratory Analysis

Laboratory Equipment

Laboratory Management

Laboratory Testing

Lift/Move 30 Pounds

Maintain Compliance

Maintenance Services

Manufacturing

Manufacturing Analysis

Manufacturing/Industrial Processes

Metrics

Microbiology

Multitasking

Organizational Skills

People Management

Performance Metrics

Presentation/Verbal Skills

Problem Solving Skills

Process Validation

Product Positioning

Purchasing/Procurement

Quality Control

Quality Metrics

Regulations

Reporting Skills

Resolve Customer Issues

Root Cause Analysis

Safety/Work Safety

Spreadsheets

Staff Training

Standard Operating Procedures (SOP)

Statistics

Supply Chain

Technical Writing

Test Data

Test Plan/Schedule

Testing

Training/Teaching

Trend Analysis

Vendor/Supplier Evaluation

Writing Skills

Assists in the implementation of new changes at the site, Provide support to collect and prepare EMPQ reports, EM Trend reports, QMR board presentations with associated documentation. Works collaboratively with other department stakeholders to ensure the services provided to the site are developed, tested, and delivered according to established procedures and regulations.

POSITION SUMMARY:Working Hours for this position will be 1300-2200. Training will be completed during day shift (0800-1700 Monday-Friday). Once training has been completed, personnel will be released to the later shift, shift pass downs sent to management will be utilized.The QC Microbiology Analyst I is responsible for performing routine microbiological sampling, testing and environmental monitoring in support of pharmaceutical manufacturing operations. This entry-level position plays a critical role in ensuring products meet regulatory and company quality standards by detecting and identifying microbial contaminants., to ensure manufactured products are appropriately measured and monitored according to Glenmark Monroe quality system requirements and regulatory guidelines (e.g., FDA 21 CFR, USP, EU Annex-1). This position is in a fast-paced, FDA regulated environment in the Pharmaceutical Industry. QC Microbiology Analyst I is a key position with expected knowledge and comprehension of basic microbiology concepts and manufacturing practices. They are responsible for ensuring microbiological and EM sampling/testing is performed in compliance with procedures and GDP requirements. This position requires a 100% on site presence.JOB RESPONSIBILITIESOperational Excellence <ul><li>Models the principles and behaviors of Glenmark and ensures personnel follow the company code of conduct.</li><li>Participate in projects, assignments, and complete presentations within timelines and budgets. </li><li>Communicate progress, status, and roadblocks as required.</li><li>Ability to perform routine sampling of utilities and EM monitoring. </li><li>Train on routine testing of samples submitted to the laboratory. </li><li>Participates in cleaning, inventory, and maintenance tasks in the lab.</li><li>Accountable for inventory of QC department laboratory supplies.</li><li>Ensures laboratory equipment is in compliance with procedures and GLP requirements prior to use.</li><li>Troubleshoots laboratory issues related to all instrumentation. Recommends potential corrective and/or preventive actions and implements these actions within the laboratory. </li><li>Performs GMP review of test data to ensure that test results meet all specifications. </li></ul>Compliance<ul><li>Train and perform on sampling of utilities.</li><li>Train on microbial testing of routine microbiology samples of water systems (e.g., bioburden, endotoxin,).</li><li>Conduct environmental monitoring of cleanrooms and controlled areas (viable and non-viable particulates, surface sampling, personnel monitoring).</li><li>Prepare and maintain microbial cultures and media in accordance with laboratory procedures.</li><li>Train on media qualifications, and microbial identifications.</li><li>Maintain current knowledge of regulatory and industry standards, trends and advancements.</li><li>Responsible for ensuring compliance to systems and procedures in the EM/Microbiology laboratory and cleanroom areas. And prepare the lab for internal and external audits.</li><li>Support Continuous Improvement initiatives by providing support on updating SOPs, WIs, and OJTs</li><li>Ensure Quality Systems are compliant with cGMPs and internal/external regulations and procedures</li><li>Assists in the implementation of new changes at the site, </li><li>Provide support to collect and prepare EMPQ reports, EM Trend reports, QMR board presentations with associated documentation. </li><li>Assist in regular self-audits of the Microbiology and EM laboratory areas (including storage areas). Assists inactivities to address audit findings.</li></ul>Stakeholder<ul><li>Works collaboratively with other department stakeholders to ensure the services provided to the site are developed, tested, and delivered according to established procedures and regulations.</li></ul>Innovation<ul><li>Consults with management, when appropriate, about laboratory supply variances. Demonstrates the ability to assess upcoming laboratory supply needs and prepare accordingly. </li><li>Demonstrates the ability to use available tools and technologies to track laboratory supply expenditures and usage. Coordinates efforts with suppliers to ensure inventory replenishment and avoid expiry. </li><li>Analyzes laboratory supply usage patterns to anticipate upcoming needs. </li></ul>Safety<ul><li>Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties</li></ul>KNOWLEDGE, SKILLS AND ABILITIESEducation (degree / diploma)Bachelor’s degree in Microbiology, Biology, or a related life science field preferred.ExperienceMinimum of 0-2 years Knowledge and Skills (Functional / Technical)<ul><li>Understanding of aseptic technique and microbiological test methods.</li><li>Strong organizational skills. Displays the ability to prioritize work and manage multiple tasks independently.</li><li>Excellent written communication and technical writing skills. </li><li>Displays strong interpersonal skills and ability to work with all levels of an organization. Clearly expresses ideas (verbal and written) and demonstrates the ability to apply a quality mindset when completing Microbiology/EM laboratory tasks.</li><li>Familiarity with regulatory guidelines (e.g., 21 CFR Part 11, USP <61>, <62>, <85>, <1116>).</li><li>Demonstrates the ability to read, understand, author, redline and execute standard operating procedures (SOPs).</li><li>Exhibits both analytical and problem-solving skills. Proven ability to problem solve/troubleshoot and provide solutions for laboratory issues.</li><li>Able to assess safety and environmental risks to ensure laboratory tasks adhere to EHS management system.</li></ul>Other requirements (licenses, certifications, specialized training)<ul><li>Ability to lift 30 lbs.’ and work within different extreme temperature / humidity environments as encountered in the various Incubator conditions. </li><li>Must be able to work in cleanroom gowning and aseptic environments.</li></ul>

QC Microbiology Analyst I

Code of Federal Regulations

Drug Manufacturing

Expense Tracking

Laboratory Techniques

Manufacturing Operations

Quality Assurance Methodology

Quality System Requirements (QSR)

Regulatory Requirements

Usage Analysis

Water Microbiology

Water Sampling

The Analytical Quality Assurance (AQA) Specialist will work with the Quality Control team to work side by side on the floor acting as an in-process quality assurance expert for microbiology and chemistry laboratory activities to include all CGMP activities and testing of any materials, intermediate/finished product, and any utility/facility testing. Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development.

Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries. Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil. Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research–based pharmaceutical company.POSITION SUMMARY:The Analytical Quality Assurance (AQA) Specialist will work with the Quality Control team to work side by side on the floor acting as an in-process quality assurance expert for microbiology and chemistry laboratory activities to include all CGMP activities and testing of any materials, intermediate/finished product, and any utility/facility testing. Working in a team environment, the AQA Specialist will provide oversite to ensure that all testing is performed in accordance with applicable procedures and compliance standards, ensure Data Integrity is maintained at all times, provide coaching and problem resolution from a Quality Assurance perspective, and act as primary reviewer of QC data for batch disposition. The AQA Specialist must be well organized and detail oriented, ensure quality events are raised in a timely manner as required.Responsibilities:<ul><li>Ensure QC processes are controlled and monitored and identify and troubleshoot any quality issues</li><li>Monitor sample custody, in-process product samples, raw materials, and environmental monitoring (EM) samples, if applicable</li><li>Support in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols</li><li>Document activities with internal reporting</li><li>Identify training needs and take action to ensure company-wide compliance</li><li>Responsible for the compilation and interpretation of QC Analytical data including OOS</li><li>Responsible to ensure that established testing control procedures and good documentation practices are followed</li><li>Ensure compliance to data integrity and cGMP in QC lab in line with standards prescribed by USFDA</li></ul>Education:Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Microbiology, or equivalentExperience:2 – 3 years in Quality Control, or equivalentKnowledge and Skills:<ul><li>Excellent analytical skills</li><li>Strong knowledge of CFRs</li><li>Strong interpersonal skills</li><li>Excellent verbal and written communication skills</li><li>Ability to work well in a team environment</li><li>Ability to work independently</li><li>Strong problem-solving skills</li><li>Strong organizational skills</li><li>Quality certifications or training a plus</li></ul>

Analytical Quality Assurance Specialist(Microbiology)

Application Programming Interface (API)

Business Plan

Clinical Research

Coaching

Corporate Compliance

Data Quality

Detail Oriented

Drug Development

Materials Testing

Needs Assessment

Procedure Development

Process Quality

Quality Assurance

Regulatory Compliance

Research & Development (R&D)

Team Player

Time Management

User Interface/Experience (UI/UX)

Preparation, review and approval of sampling matrix and hold time schedule Conducts and communicates results of lab investigations when test results fall outside pre-established specifications and/or limits (OOS/OOL). Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development.

No Visa Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business. The subsidiary also markets APIs to regulated and semi-regulated countries.POSITION SUMMARY :The Microbiology Analyst is responsible for performing microbiological tests that support the release of intermediates and finished products. These include routine and non-routine microbiological tests on in-process and final container products, as well as environmental monitoring samples. This position also contributes to the completion of regular routine technical tasks.JOB RESPONSIBILITIES :Help maintain inventory by reporting needed supplies. Take appropriate steps to reduce wastages and losses in the Microbiology department.<ul><li>Monitoring samples, in-process product samples, raw materials, and environmental monitoring (EM) samples.</li><li>Successfully complete a gown qualification program to enter and work inside the aseptic manufacturing area.</li><li>Perform critical manufacturing process interventions for viable and non-viable EM.</li><li>Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples.</li><li>Perform routine sampling of critical process utilities (e.g., Water-for-Injection, Purified Water, Clean Compressed Air, Nitrogen Distribution System, etc.)</li><li>Count colony forming units (CFU) on Petri plates.</li><li>Perform sterility testing on final products and raw materials.</li><li>Perform Growth Promotion and Biological Indicator testing.</li><li>Perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods.</li><li>Maintain accurate and complete test records.</li><li>Enter test results in the Laboratory Information Management Systems (LIMS).</li><li>Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.</li><li>Maintain current knowledge of regulatory and industry standards, trends and advancements.</li><li>Other duties as identified by direct supervisor</li><li>Preparation, review and approval of sampling matrix and hold time schedule Conducts and communicates results of lab investigations when test results fall outside pre-established specifications and/or limits (OOS/OOL).</li><li>Performs routine equipment maintenance.</li><li>Performs maintenance of spare parts inventory, calibrations and supervises third party maintenance and repair when necessary.</li><li>Establishes good working relation with contract laboratories.</li><li>Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols.</li><li>Supports activities regarding audits of suppliers and contract labs in support of vendor certification program.</li><li>Conducts statistical evaluation of the manufacturing and inspection process and training QC staff.</li><li>Assures laboratory databases are maintained and accurate.</li><li>Ensures control of laboratory documentation (Raw Material COA, testing instructions, testing.</li><li>Ensure that all equipment is calibrated.</li></ul>Education :<ul><li>Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or equivalent.</li><li>Microbiology degree preferred</li></ul>Experience :<ul><li>1-3 years of experience in a cGMP/GLP laboratory.</li><li>Pharmaceutical & FDA/GMP industry experience is preferred.</li><li>Microbiology laboratory experience, such as aseptic techniques required</li></ul>Knowledge and Skills :<ul><li>Knowledge of current cGMP regulations for laboratory setting</li><li>Proficient in Windows, Microsoft Word, Excel.</li><li>Good written, verbal, and communication skills.</li><li>Good documentation skills.</li><li>Strong organizational skills.</li></ul>

Microbiology Jobs in Huntersville, NC

Resume Resources

Get noticed by top employers!

Microbiology Jobs in Huntersville, NC

Senior Microbiology Analyst Glenmark Pharmaceuticals Inc.

QC Microbiology Analyst I Glenmark Pharmaceuticals Inc.

Analytical Quality Assurance Specialist(Microbiology) Glenmark Pharmaceuticals Inc.

Microbiology Analyst Glenmark Pharmaceuticals Inc.

Resume Resources