Quality Assurance Batch Specialist

3 days ago

Fishers, United States INCOG BioPharma Services Full time

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, and patients.


Job Functions:


  • Independently manage day to day projects and/or team activities and issues on global projects across multiple organizations, geographies, and business areas.
  • 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, approval of Batch Records and 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.
  • 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.
  • 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.


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.
  • 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


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.

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