QA Lead investigator

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Almac Group is currently seeking a QA Lead Investigator for our Audubon, PA location. The QA Lead Investigator position supports the QA organization within Almac Pharma Services. This position coordinates and leads investigations related to reported non-conformances/deviations and defects within a GMP environment
 
Responsibilities include but are not limited to:
  • Ensure timely completion of investigations/Product Complaints through the following activities to include but not limited to:
    • Coordinate immediate actions in conjunction with QA and department management upon identification of a non-conformance
    • Interview Subject Matter Experts (SMEs) and involved employee(s) across multiple shifts to investigate reported problems and assess the quality impact
    • Conduct investigational meetings with required team member(s)
    • Verify Investigational findings against documented process per SOP.
    • Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causal factors
    • Work with cross functional team member(s) to develop appropriate CAPA actions
    • Author/draft investigation reports with minimal guidance.
    • Ensure investigations, corrections and CAPA are generated and closed out in a timely manner
  • Identify and analyze trends arising from individual investigations
    • Support and/or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms
    • Act as liaison as it relates to specific investigations during client calls and audits
    • Report the performance of the quality system as a basis for improvement of the quality system
  • Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trends
    • Manage, conduct/coordinate, track, and follow-up of activities related to trend CAPA’s
    • Coordinate the review of trend CAPA’s to determine their effectiveness
  • Support and/or perform tasks within other QA departmental disciplines including but limited to audits and process improvements as assigned by management.
 
Qualifications:
Required Experience / Education:
  • High School Diploma or GED
  • 3 years in Pharmaceutical or similar GMP environment
  • 2 years experience authoring/leading investigations in a Pharmaceutical Manufacturing or Packaging environment
  • Pharmaceutical or similar GMP environment
Preferred Experience / Education:
  • Bachelor’s Degree
  • 5 years in Pharmaceutical or similar GMP environment
  • 1 year experience with the generation, execution and review of quality documents in a commercial pharmaceutical packaging facility.
  • Root Cause Analysis
  • Investigations/Technical Writing Training
  • Trackwise or other electronic systems
What Almac Group can offer YOU!
  • Full medical, vision & dental benefits the 1st of the month after start date
  • 20 days of PTO to start plus 12 holidays per year
  • Company paid long and short term disability along with life insurance
  • 401k company match
  • Professional development programs/ continuous learning opportunities
 
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry.  We are a privately owned organization that has organically grown over 50 years now employing almost 5,600 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
 
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
 
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
 
 
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process.  Please email us at [email protected] to request assistance.
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