What are the responsibilities and job description for the QA Specialist, Batch Review position at Lead Candidate?
QA Specialist, Batch Review
Who
INCOG are looking for a Quality Assurance Specialist – Batch Review who will oversee review processes for Manufacturing Batch Record lifecycle activities, including Formulation, Filling, Inspection, Labeling and Packaging, and final-stage review and disposition at a new state-of-art contract development and manufacturing organization.
1st shift and 2nd shift available
What
Working closely with the QA Supervisor, the QA Specialist – Batch Review will be instrumental in supporting major QA programs. They will also be key in championing and developing the organization’s Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. The QA Specialist – Batch Review will at all times provide support with identifying and closing Operational and Quality gaps.
- Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product.
- Provide Client access and support in the review and approval of Batch Records.
- Provide training to all QA Associates and Specialists on surveillance oversight and on-the-floor Batch Record review requirements.
- Support Quality Systems with driving timely completion of batch impacting deviations to support on time batch release activities.
- Create and report batch release metrics to site leadership.
- Participate in operations investigations for determining root cause and assessing mitigation for Major and Critical deviating events.
- Support authoring, reviewing and approving of various SOPs & Work Instructions.
- Support Plant Automation alarm reviews.
- Advise and approve the builds of Batch Record BOMs and ECOs.
- Prioritize and coordinate their time in balancing production timelines with product quality assurances.
- Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution.
You!
- Bachelor’s Degree required or equivalent; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.).
- 4 years minimum experience working in a GMP environment.
- 2 years minimum experience working with aseptic processing in cleanroom and/or isolator environments required.
- Excellent written and verbal communication skills.
- General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).
Why INCOG?
- Paid time off, based on tenure
- 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
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Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.