Data Reviewer II

Quality Control Data Reviewer in Rensselaer, NY

Build your future at Curia, where our work has the power to save lives. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives. We proudly offer:

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

The Quality Control Data Reviewer II is an integral part of the Curia team and is responsible for supporting manufacturing department and external customers. The routine functions of the laboratory are testing of raw materials, in-process, end product, and stability samples. The principal responsibility of this role is the review and approval of primary analytical data according to cGMP guidelines.

The QC Data Reviewer will be expected to review analytical data including HPLC, KF, USP testing for compliance and completeness against established SOPs, methods and procedures. This position will also support QA initiatives when necessary and collaborate with laboratory personnel to review data per cGMP compliance and data integrity. The Reviewer should incorporate sound judgement, critical thinking, and cGMP principles to ensure the integrity of the data meet acceptable quality standards. In addition, the Reviewer will provide appropriate guidance to analysts, supervisors, and quality personnel to promote compliance for our customers.

Join our talented workforce, where a commitment to excellence and a customer-focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture.

Essential Duties and Responsibilities

• Review data generated from various analytical instrumentation including but not limited to Gas Chromatography (GC), high-performance liquid chromatography (HPLC/UHPLC), Infrared spectroscopy (IR), Differential scanning calorimeter (DSC), UV-Vis, Karl-Fischer auto titrator, Optical rotation, Dissolution, etc.
• The review entails a technical data review of the raw data generated for various compendial testing (such as USP/NF, EP, JP, etc.) as well as Curia In-house and client methodologies for various client projects to ensure data accuracy, completeness and integrity
• Perform electronic review and signatures while reviewing electronic data
• Verify for traceability of samples, standards, reagents, instruments etc.
• Verify the usage logbook, calibration of instruments and shelf life of standards and reagents used are current and GDP procedures are followed
• Verify calculations associated with testing are correctly done per procedures
• Responsible to escalate OOS's identified in data review to the QC and QA leadership
• Verify chromatography associated with the testing does not include any trial injections
• Promptly ensure the corrections identified from the data review are addressed per approved procedures
• Format and review Stability summary tables, Stability Protocols for accuracy and compliance with current Curia formats
• Enter data into Stability summary tables
• Perform tracking and trending of data as requested
• Compile data and provide data summaries to management
• Ensure all tests are per cGMP compliance and in compliance with the company's standard operating procedures
• Provide support on QA initiatives (Investigations, change controls etc.) when necessary
• Ensure the testing data received from external labs are reviewed per site procedures
• Ensure any manual integrations in chromatography is appropriately authorized by QC leadership
• Provide training to new hires as needed
• Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures
• Perform other related duties as may be reasonably assigned in the course of business

Requirements

• Bachelors Degree in Natural Science, Pharmacy or equivalent
• Minimum 5-8 years in QC operations or relevant industrial experience
• Experience working in cGMP or GLP pharmaceutical industry environment
• Preferred Experience in commercial QC laboratories
• Knowledge, skills and abilities
• Chemical Hygiene training
• Working knowledge and understanding of various analytical instrumentation including but not limited to Gas Chromatography (GC), High-performance liquid chromatography (HPLC/UHPLC), Infrared spectroscopy (IR), Differential scanning calorimeter (DSC), UV-Vis, Karl-Fischer auto titrator, Optical rotation, Dissolution, etc.
• Understand and interpret complex analytical techniques such as Method Validation, Method Transfer, Method Verification, Stability testing methodologies
• Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
• Ability to meet deadlines and work under pressure with limited supervision
• Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently
• Ability to apply mathematical concepts, operations and tasks
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Proficient in Microsoft Office Suite and instrument manufacture-based systems
• Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this Job, the employee is regularly required to talk or hear.
• The employee is frequently required to sit; use hands to finger, handle, or feel and reach with hands and arms.
• The employee is occasionally required to stand; walk; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
• The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this Job, the employee is frequently exposed to fumes or airborne particles and toxic or caustic chemicals.
• The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; risk of electrical shock; explosives; risk of radiation and vibration.
• The noise level in the work environment is usually moderate.

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• Pay Range: $63,000-$79,000/year
• Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
• We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings.
• All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
• All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.
• Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
• Curia is an E-Verify employer. #LI-DR1