UNKNOWN

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Position Summary: Under general direction, perform microbiology/EM testing and other activities in functions supporting the Quality Control department. • 1 - 3 years of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.

Position Title: Associate Expert Microbiology Work Location: East Hanover, NJ 07936 Assignment Duration: 12 Months Work Schedule: Work in shifts covering daytime hours from 12 PM to 8 PM and work one or both weekend days at least once per month. Shifts will be fixed based on business needs. Work Arrangement: Onsite Position Summary: Under general direction, perform microbiology/EM testing and other activities in functions supporting the Quality Control department. Key Responsibilities: • Perform micro/EM testing in support of clinical release strategies.• Perform all testing and activities compliantly following appropriate SOPs and procedures.• Maintain controls and reference standards to support testing.• Executes and follows SOPs, WPs, and quality policies.• Peer review and archive analytical data in lab documentation systems.• Support monthly/quarterly laboratory cleaning.• Appropriate use of laboratory logbooks and monthly laboratory cleaning.• Manage reagent/consumable inventory and equipment cleaning for assigned areas of responsibilities.• Ensures cleanliness of laboratory working areas.• Support and author OOS/OOE/OOT and deviation investigations.• Participate in CAPA implementation in a timely manner.• Follows GxP quality policies and procedures.• Ensures all assigned training is completed within required time frame.• Support 5S and Lean projects.• Identify process improvements.• Knowledge of LabWare, LIMS and/or other QC data systems.• Knowledge of appropriate GMP/GLP quality systems (e.g., ESOPs, Trackwise, 1QEM, BMRAM, etc.).• Support execution method qualification/optimization of methods.• Interface with regulatory agencies during audits as required.• In addition to these primary duties, provide coverage for all appropriate areas.• Contributes to assigned projects by following predefined tasks and executing as instructed.• Perform other job duties as assigned.• Collects and generates data for trend reporting.• Verify the accuracy of data generated.• Contributes to the gowning qualification program by taking samples and analyzes and generates data. Qualification & Experience: • BA/BS or MS or advanced degree in microbiology, biology, biochemistry, or other related science or equivalent work experience.• Fluent in English.• 1 - 3 years of relevant experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.• Knowledge of cGMP and an understanding of the concepts of GDP, good clinical practices and FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e., ANSI, ISO, etc.).• Thorough knowledge of microbiological and environmental monitoring, test methods.• Microbiology/Environmental Monitoring knowledge to facilitate investigations.• Knowledge of LIMS systems.• Ability to communicate clearly with a variety of individuals in various aspects of our organization operations.• Detail-oriented with expertise in problem solving and solid decision-making abilities.• Strong interpersonal skills which include a professional demeanor when interacting with our organization personnel.• Strong written and verbal communication skills are essential.<ul><li>Connecting media strategy with loyalty strategy</li><li>Conduct business strategy reviews to assess progress of strategy achievement</li><li>Spanning growth strategy and continuous development</li><li>Developing business and operational strategy around technology</li><li>Leverage strategy and analytics partners</li><li>Ensure ongoing alignment with strategy</li><li>Develop the content strategy including website content</li><li>Providing content, strategy and design recommendations</li><li>Providing analytical and strategic support to the pricing strategy lead</li><li>Provide analytical support to the strategy development process</li><li>Develop new and ongoing efforts for business strategy</li><li>Spearheading and leading innovative sourcing strategy projects</li><li>Identifying the correct strategy for tool</li><li>Guiding the development and launch of digital marketing strategy across channels</li><li>Conduct projects to drive Level 3's market evolution, product strategy, and/or overall business strategy</li><li>Translate market opportunities into concrete product strategy and tactical roadmaps</li><li>Develop a proactive workforce strategy and plan</li><li>Reviewing the process and strategy of investment portfolio implementation</li><li>Organize strategy material and transaction documentation</li><li>Implement strategy for innovative solutions and superior services</li></ul>

Spectraforce is a leading global services firm that provides a portfolio of Consulting, Staffing and Outsourcing services & solutions to a broad range of clients and industries worldwide. We are headquartered in Raleigh, NC, USA and have offshore global delivery centers at Pune, Chandigarh, and Hyderabad, India. At Spectraforce we have a Philosophy - a Philosophy that excellence is derived through dedicated, focused and innovative work. We also believe that knowledge comes through sharing and growth comes to every organization where people use knowledge in team work. A progressive culture and a world of possibilities is what you see with us.

Spectraforce Technologies Inc

Associate Expert Microbiology/ Microbiologist/ Microbiology Technician

American National Standards Institute (ANSI)

Analysis Skills

Biochemistry

Biology

Biotech and Pharmaceutical

Business Development

Business Operations

Business Strategy

Channel Marketing

Cleaning Equipment

Cleanroom

Clinical Support

Communication Skills

Concrete

Content Development

Corrective and Preventative Action (CAPA) Systems

Current Good Manufacturing Practice (cGMP)

Data Analysis

Data Collection

Data Quality

Detail Oriented

Documentation

English Language

Environmental Microbiology

Environmental Monitoring

FDA (Food and Drug Administration)

GCP (Good Clinical Practices)

GLP (Good Laboratory Practices)

GMP (Good Manufacturing Practices)

Housekeeping/Cleaning

ISO (International Organization for Standardization)

Interpersonal Skills

Investment Strategy

Laboratory Analysis

Laboratory Information Management System (LIMS)

Labware

Marketing Strategy

Medical Equipment

Microbiology

Online Marketing

Operational Strategy

Presentation/Verbal Skills

Problem Solving Skills

Process Development

Process Improvement

Product Pricing

Product Strategy

Project Tracking

Quality Assurance Methodology

Quality Control

Regulations

Sourcing Strategy

Standard Operating Procedures (SOP)

State Laws and Regulations

Strategic Analysis

Strategic Planning

Technical Strategy

Testing

Time Management

Training/Teaching

Trend Analysis

Workforce Planning

Writing Skills

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Execute environmental monitoring of classified cleanrooms and controlled environments, including viable air sampling and non-viable particulate monitoring, surface sampling (RODAC/contact plates and swabs), personnel monitoring. * Support aseptic processing activities, including Gowning and working in classified cleanroom environments, monitoring aseptic operations for extended durations, Assisting with aseptic process simulations (media fills).

Out client is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. They have a long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada. POSITION SUMMARY The Microbiologist - Sterile is responsible for supporting sterile manufacturing operations by performing microbiological testing, environmental monitoring, and aseptic process support activities. This role ensures compliance with current Good Manufacturing Practices (cGMP), including 21 CFR Parts 210/211, 820, ISO 13485, and EU Annex 1 requirements. The position plays a critical role in maintaining the microbiological control of aseptic processing environments used in the production of sterile injectable products. ESSENTIAL FUNCTIONS *	Microbiology laboratory operations include ordering supplies, preparing media, disinfectant preparation, cleaning, operating laboratory equipment, sample receipt, documentation, following good documentation practices. *	Perform routine and specialized microbiological testing and assist senior microbiologist to support sterile manufacturing operations, including water, steam, and environmental monitoring programs. *	Conduct testing such as bioburden, endotoxin (LAL), sterility, biological indicators, and growth promotion in accordance with USP requirements. *	Execute environmental monitoring of classified cleanrooms and controlled environments, including viable air sampling and non-viable particulate monitoring, surface sampling (RODAC/contact plates and swabs), personnel monitoring. *	Support aseptic processing activities, including Gowning and working in classified cleanroom environments, monitoring aseptic operations for extended durations, Assisting with aseptic process simulations (media fills). *	Perform sampling and testing to support cleaning validation and verification programs, including swab and rinse sampling. *	Assist in process validation activities related to sterile manufacturing and aseptic processing. *	Perform microbial identification, gram staining, and evaluation of colony morphology. *	Maintain working knowledge and application of relevant USP chapters, including USP <51>, <61>, <62>, <71>, <85>, <1035>, and <1111>. *	Ensure proper documentation practices in compliance with GDP (Good Documentation Practices), including data recording, logbooks, and electronic systems. *	Support investigations related to out-of-specification, out-of-trend, and environmental monitoring excursions; assist in root cause analysis and corrective actions. *	Participate in trending and reporting of environmental and utility monitoring data. *	Prepare, review, and revise SOPs, protocols, reports, and risk assessments to ensure regulatory compliance. *	Maintain laboratory operations, including media preparation and inventory management, equipment cleaning, calibration coordination, and maintenance, disinfectant preparation and laboratory sanitation *	Support internal, customer, and regulatory audits. *	Coordinate sample shipment to contract laboratories and review test results for compliance. *	Ensure proper handling and disposal of biological and hazardous laboratory waste. *	Comply with all safety, GMP, and company policies while performing assigned duties. *	Collaborate cross-functionally with Quality, Manufacturing, and Validation teams to support sterile operations. *	Participate in Goods Receipt issuance for microbiology laboratory services as needed. POSITION QUALIFICATIONS *	Excellent verbal and written communication skills with the ability to effectively present within all levels of the organization and clients. *	Flexibility to work weekends or extended hours as required by manufacturing schedules. *	Strong understanding of microbiological principles and sterile/aseptic manufacturing environments. *	Hands-on experience with microbiology testing, environmental monitoring in cleanroom environments. *	Familiarity with regulatory requirements for sterile manufacturing, including cGMP and EU Annex 1. *	Working knowledge of USP microbiological methods, especially USP <60>, <61>, <62>, <71>, and <1111>. Experience with endotoxin, sterility, and bioburden testing required. *	Knowledge of TOC, Conductivity, and Nitrate testing is a plus. *	Experience with quality systems and software such as TrackWise, SAP, MasterControl, and Novatek (stability software) is a plus. *	Ability to work independently with minimal supervision in a fast-paced, regulated environment. *	Handle hazardous and biological waste generated by microbiology laboratory. *	Adherence to regulatory/in-house requirements (may include but limited to safety, housekeeping, laboratory biological/chemical waste, cGMP, GLP, documentation) when performing assigned activity. *	Use of personal protective equipment to limit exposure to chemicals, biological or other hazards found within a laboratory environment. *	Ability to work collaboratively with other team members to ensure successful outcomes. *	Strong attention to detail and ability to produce accurate, compliant documentation. *	Proficiency in Microsoft Office applications (Word, Excel), and other laboratory information management systems. EDUCATION: Bachelor"s degree in microbiology, Biology, or a related scientific discipline required. Equivalent experience may be considered. By applying for this job, you agree to receive calls, Al-generated calls, text messages, or emails from Synerfac Technical Staffing and our contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undeliverable messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at www.synerfac.com/privacy/

Synerfac Technical Staffing

microbiologist

Asepsis

Calibration

Code of Federal Regulations

Contract Manufacturing

Contract Review

Corporate Policies

Corrective Action

Cross-Functional

Dosage Forms

Environmental Work

Hazardous Materials/Substances

Inventory Management

Laboratory Equipment

Laboratory Operations

Laboratory Testing

Maintain Compliance

Manufacturing

Manufacturing Operations

Manufacturing Requirements

Media Inventory

Microsoft Excel

Microsoft Office

Microsoft Word

Operational Support

Order Supplies

Process Validation

Production Schedule

Regulatory Compliance

Regulatory Requirements

Risk Analysis

Root Cause Analysis

Safety Compliance

Sanitation

Specimens/Samples

Team Player

Validation Testing

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Associate Expert Microbiology/ Microbiologist/ Microbiology TechnicianSpectraforce Technologies Inc

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