Job Title: QA Specialist II

Work Location: Bergen County, New Jersey

Summary:

Plan and implement quality requirements and provide Quality oversight in manufacturing operations at the site. As part of an inter-departmental team environment, collaborate with subject matter experts to resolve any Quality issues, enable lot disposition, improvements for new and existing clients. Additionally, the role will include being the QA single point of contact for major clients. Reviews manufacturing batch records in accordance with cGMP, reviews and approves low level non-conformances and deviations, approves Certificate of Testing (CoT), Certificate of Analysis (CoA), and Certificate of Processing (CoP) for manufactured batches in accordance with cGMP. Author and revise departmental SOPs to stay current with changes to GxP including FDA, EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.)

Responsibilities:

• Job is 100% on-site.
• Review and approve Deviations and Low level Non-conforming events (NCE).
• Knowledgeable on review and approval of document change requests and Change Control.
• Conducts review of pre-executed and executed Manufacturing batch records in accordance with cGMP and internal procedures in an efficient and timely manner. Assure that investigations/deviations are properly investigated and documented.
• Prepares Manufacturing release checklist and COA’s.
• Review and approve Aseptic Processing Validation (APV) batch records, APV summary reports, Label Specification Sheets (LSS) and Product Specification Sheets (PSS).
• Approves CoA’s, CoP’s, or CoT’s for executed Manufacturing batch records in accordance with cGMP and internal procedures in an efficient and timely manner.
• Ensure QA checklist is adequate and comprehensive to enable batch disposition.
• Interacts with manufacturing management to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel and determine if issues can be addressed with batch record comments or require escalation.
• Interacts with or represents QA in project teams to assure that project requirements and details are understood and effectively translated into MFG records.
• Communicate project requirements across the team and establish a timeline to enable batch release.
• Writes, reviews and revises SOP’s as required.
• Participates/leads internal, supplier and client audits, and regulatory inspections.
• Participates/leads internal facility walkthrough in manufacturing areas and warehouses.
• Participate in quality and process improvement initiatives and project teams.
• Acts as QA single point of contact for designated clients.
• Attend meetings and represent QA Manufacturing for Quality issues.
• Given authority to make decisions and sign documents on behalf of QA Manufacturing.
• If required to become qualified for visual inspection. Selected individuals are required to inspect the final product in a light booth to detect defects and record the pass/fail results of their inspection.

Qualifications:

• 3+ years of relevant experience in the biopharmaceutical industry.
• Bachelor’s degree in a Science related field preferred; diploma acceptable with relevant experience.
• Pharmaceutical experience in QA required.
• Knowledge of cGMP requirements.
• Ability to accomplish the duties described using appropriate computer equipment and software (Microsoft Word, Excel, and Access).
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Builds productive internal/external working relationships. Receives general instructions on routine work.
• Proficient in Oral & Written communication skills.
• Ability to record data accurately and legibly.
• Ability to understand and follow verbal or demonstrated instructions.
• Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.
• Flexible in managing deliverables and working hours to meet business objectives.
• Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Displays good level of problem-solving ability and offer suggestions to supervisor/management on complex issues.
• Sound knowledge and interpretation of FDA and EU cGMP requirements.
• Extensive experience writing, reviewing, and approving NCEs/DEVs preferable.
• Ability to work effectively as part of a team and exhibit excellent interpersonal skills.

Published Category: Quality & Validation