QA Batch Specialist 2nd Shift

QA Batch Specialist 2nd Shift

Who

INCOG Biopharma Services in Indianapolis, IN are looking for a Senior QA Specialist of Batch Disposition to join their rapidly growing team.

At INCOG, we are more than just a contract development and manufacturing organization. We are a company born out of a simple idea—that there has to be a better way. A better way to work with our customers. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are—a dedicated team that believes we can always be better.

Join us in building a new world-class CDMO for parenteral injectable drugs and shaping a new future for patients for yourself, our clients, and patients.

This is a 2nd shift position (3pm to 11:30pm).

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.
• Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.
• Utilize various paper and automated systems (eDMS, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.
• Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.
• Ability to manage multiple projects in a fast-paced environment.
• Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.

You

Candidate Requirements:

• 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.).

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 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

Curious? Send us your resume at apply@leadcandidate.com or you can find more information on our website.

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.