Senior Quality Assurance Specialist

11 hours ago

Fishers, United States INCOG BioPharma Services Full time

Senior Quality Assurance Specialist


INCOG Biopharma Services in Indianapolis, IN is hiring a Senior Quality Assurance Specialist. They are looking for a Senior Quality Assurance Specialist specializing in Technical Operations who will support oversight of technical operations with review of Technical Transfer documents, Master Batch Records, client specific needs, etc. This role supports filling and inspection/packaging activities at a state-of-art contract development and manufacturing organization.


Working closely with the QA Operations Manager, the Senior QA Specialist will be instrumental in supporting major QA programs. They will also be key in championing and progressing the organization’s Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. The Senior QA Specialist will at all times provide support with identifying and closing Operational and Quality gaps.


The Senior Quality Assurance Specialist will exemplify excellent interpersonal skills and will 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 thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The Senior QA Specialist will value process owners and subject matter experts and will possess a demonstrated ability to influence 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 contract development and manufacturing organization. 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, their clients, and patients.


Job Functions:


  • Review and approve documentation for Quality approval, including but not limited to: Technical Transfer risk assessments and summaries, Master Batch Records (MBRs), Process Performance Qualification (PPQ) protocols and summaries, etc.
  • Collaborate with Manufacturing Sciences & Technology (MSAT) and Manufacturing to ensure the product technical transfers and MBRs align with INCOG’s manufacturing processes and standards.
  • Represents INCOG Quality Assurance with direct interaction with clients, including but not limited to weekly project meetings, Technical and QA discussions, reviewing client provided documents, escorting clients during onsite manufacturing activities as needed, etc.
  • 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.
  • 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.
  • Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, laboratory instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.


Candidate Requirements:


  • Bachelor’s Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology, etc.)
  • Minimum of 8 years of experience working in a GMP manufacturing environment.
  • Minimum of 4 years' experience of QA oversight for GMP manufacturing.
  • Experience as performer or reviewer in Quality Management Systems, DMS, Deviation/CAPA, and Change Control required.
  • Extensive knowledge of regulations and quality processes involving product disposition. • 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.).
  • Occasional weekends and evenings may be required to help support client activities.


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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