QA Batch Review Specialist

QA Batch Review Specialist

INCOG Biopharma Services in Indianapolis, IN is hiring an QA Batch Review Specialist. They are seeking a highly motivated individual and detail-oriented 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.

Working closely with the QA Manager, 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 successful individual will, at all times, provide support with identifying and closing Operational and Quality gaps.

The QA Batch Review Specialist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and external partners and clients. They will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. They will also thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. QA Batch Review Specialist will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, INCOG’s clients.

Job Functions:

• 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.
• 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, also advise and approve the builds of Batch Record BOMs and ECOs.

Candidate Requirements:

• Bachelor’s Degree required; 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.

Additional Preferences:

• 3 years experience as performer or reviewer in Quality Management Systems, DMS, Deviation/CAPA, and Change Control required.
• 2 years’ experience with assessment and review of Quality Control testing, CoA, and results management preferred.
• Extensive knowledge of regulations and quality processes involving product disposition.

Why INCOG?

• Paid vacation days, amount based on tenure, and paid sick time
• 11 observed holidays
• 401(k) plan with company match up to 3.5% of salary, vested immediately.
• Choice of health & wellness plans.
• FSA and HSA programs.
• Dental & vision care
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Reach out to Connor at connor@leadcandidate.com to find out more!

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

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.