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Specialist, Operations Biologics Development Quality Assurance

Newark Metro Area, NJ

Posted: 03/04/2019 Job Type: Scientific Job Number: JN -032019-23835
The Biologics Specialist Development QA is primarily responsible for development batch records reviews to ensure that the records meet cGMPs and submission requirements. The Biologics Specialist Dev QA also has additional responsibilities to ensure that Global Quality Operations Development maintains compliance in assigned responsibilities that include but are not limited to, non-batch record document reviews, temperature excursion assessments, authoring documents, use-by-date/retest date, extensions, deviations & complaints investigator and record archiving.

1) Perform Development Biologics Batch Record Review Function: Conducts batch record review of
biologics development batches of drug substance, drug product and package/labeling jobs. Provides input on clinical product disposition. Establishes positive relationships and interfaces with
contract manufacturers and testing laboratories to communicate and promptly resolve quality
issues. May represent QA on assigned project and development product teams. Notifies
senior management regarding quality issues as required by site procedures and prepares
reports as requested. Tracks and reports performance metrics as required.
2) Perform Document Review Function: (and may approve as required) SOPs, supporting batch
documentation, deviations, complaints, temperature excursions, retest/use-by dating. Notifies
senior management regarding quality issues as required by site procedures and prepares
reports as requested. Tracks and reports performance metrics as required.
Compliance Systems: Implements and maintains the activities for development batch record
review, SOP review, temperature excursions, dating extensions, complaints handling,
document archival, in compliance with cGMPs, SOPs, good documentation practices and in
accordance with corporate, regulatory and project timeline expectations.
4) Vendor Contacts: Communicates as required, with outsourced manufacturing,
packaging/labeling and/or testing service providers regarding quality assurance issues noted
during reviews.
5) Communications: Proactively communicates, works with and provides timely services to staff
and internal colleagues in QA, QC, AR&D, Drug Substance Development (DSD) and Drug
Product Development (DPD), Investigational Materials Supply Chain (IMSC), Information
Systems, Metrology, Facilities and Training groups.
6) Human Resources: Ability to function in a fast-paced environment and anticipate/adapt to
changing needs and priorities. Consistently meets performance objectives. May be asked to
assist in the evaluation of prospective employees for the quality assurance department.
7) Perform other tasks as assigned.

Knowledge, Skills, and Abilities

BS/MS in a related scientific discipline.
2-4 years experience within QA functions in pharmaceutical industry
Thorough knowledge of cGMP in the pharmaceutical industry. Good understanding of drug
development process. Biologics experience a plus.
Knowledge and application experience with batch record review, product disposition/release,
change control, SOP review, contractor management, qualification and validation review,
technology transfer, management notification processes
Good computer skills and working knowledge of common business software
Excellent organizational skills
Excellent problem-solving, verbal and written communication skills
Must have strong interpersonal and communication skills, be a team player
Must be an individual with proven initiative and demonstrated accountability
Professional integrity and maturity are required

Bachelors degree in a scientific discipline or an equivalent combination of education and relevant
work experience may substitute.

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