05.12.22

QA Associate

If you’re looking to be part of something special, making a difference to society through improved patient therapies and care, this could be the opportunity for you.

Lead Candidate are delighted to be working with the team at INCOG BioPharma Services as they build a world class CDMO. As they build a world-class CDMO for parenteral injectable drugs in Fishers, Indiana, they are in the process of constructing the GMP facility and organization from the ground-up, which provides the opportunity to leverage knowledge gained over multiple careers to “do it right” in all respects.

The Opportunity

To fuel their growth journey, INCOG are looking for a QA Associate who will work closely with the QA Manager and will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization’s Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery.

This is where you come in! If you crave the challenge of creating new systems and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you.

Working closely with the QA Manager, the role will include the following responsibilities:

  • QA release of raw materials
  • Operational line Clearances and AQL Inspection of final product
  • Product Reserve/Reference sample collection and coordination
  • Review of Batch Records and other documentation in support of final product disposition
  • Deviation triage, tracking/trending, and investigation support

Some other key aspects of the role include:

  • Review and approve documentation for Quality approval, including but not limited to components/raw materials, batch records, change control requests, deviations and validation documents, etc.
  • Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations.
  • Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor.
  • Prioritize and coordinate 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.

You

The successful candidate will have experience working in Quality in a Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment.

Alongside this, you’ll also have:

  • You will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners.
  • You will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences.
  • Minimum of 3 years of Quality Assurance experience in biopharma or similarly regulated industry.
  • Certification(s) in Risk Management, Quality Process Analysis, Technical Writing, and/or Quality Investigation.
  • Hands-on experience with aseptic manufacturing Quality.
  • Experience with Continuous improvement, Six Sigma, and/or Lean principles.

This is an opportunity to be involved in building a new world-class CDMO for parenteral injectable drugs and shaping a new future for patients for yourself, clients, and patients. With an organization that values excellence, innovation, accountability, partnership, transparency, and results. They strive to deliver their work by putting the team at the forefront of everything they do and every decision they make.

Lead Candidate are delighted to be partnering with the team at INCOG BioPharma Services and would love to tell you more about the future of this innovative organisation. If you want to learn more, then please contact one of our Talent Champions today at apply@leadcandidate.com

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