Quality Assurance Associate

2 days ago

Fishers, United States Lead Candidate Full time

Quality Assurance Associate (3rd Shift)


INCOG Biopharma Services in Indianapolis, IN is hiring a Quality Assurance Associate for their 3rd shift operation. They are seeking a highly motivated individual who will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs, and identifying operational and quality gaps. . They will also provide support in championing and developing the organization’s Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery.


The QA Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences, and will thrive in a team environment whilst also work autonomously utilizing strong self-management and organizational skills. The individual 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, and INCOG’s clients.


Job Functions:


  • This position will support primarily third shift (11:00pm-7:30am) with occasional weekend support, dependent on operations’ needs.
  • Maintain a QA presence and provide process confirmation on the manufacturing floor, coordinating own time with production timelines and product QA.
  • Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, material release etc.
  • Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations. Exercising 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.
  • Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.
  • Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.


Candidate Requirements:


  • Bachelor’s Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
  • At least 2 years’ experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment.
  • Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc..
  • Understanding of Good Documentation Practices (GDPs) and its criticality.


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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