2 hours

QC Team Leader

Almac Group, Inc
Audubon, PA 19403

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 5,000 highly skilled personnel worldwide.  Our Global headquarters is located in Craigavon, Northern Ireland with additional operations throughout Europe (UK, Ireland), across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Japan). 


 


Our drive and passion for the values championed by our Founder, and enshrined in the ethos of Almac, ensures that Partnering to Advance Human Health is more than just a tagline it is our way of life.




We are currently looking for a QC Team Lead for our Audubon, PA facility. The QC Team Lead will lead a team of Quality Control staff to ensure that schedules are met and that analytical testing and QC inspection activities are performed in compliance with the principles of current Good Manufacturing Practice and the Almac Pharma Services quality management systems.



Responsibilities include but are not limited to:


 



  • Supervise a team of Quality Control staff conducting routine tasks including identity testing of products by HPLC / FTIR / UV etc, incoming inspection of starting materials, inspection of finished products and assessment of cleaned equipment by swab analysis.

    • Ensure that resources are allocated and activities are scheduled to provide an effective and timely service to support business requirements

    • Ensure that all analysis and associated tasks are performed in accordance with quality policies and procedures, satisfy the requirements of cGMP and are in accordance with the appropriate regulatory guidelines.



  • Ensure that Quality Management System documents (Deviations, CAPA, Change Control and Suspect Analytical Result Reports) are raised and closed out promptly

  • Provide quality authoring, review and/or approval of GMP records including SOPs, Policies, Guidelines, specifications analytical data packs, environmental monitoring data, calibration records and validation documentation

  • Ensure adequate supplies of materials and consumables are available to support projects and that purchase orders are created with appropriate project coding; Ensure QC equipment maintenance is appropriate including coordination instrument calibrations

  • Manage the environmental monitoring program for all GMP areas on site.

  • Regulatory Inspections / Client Audits Participate in the preparation for, and hosting of, regulatory and client audits of the Almac Pharma Services facility and operations.

  • Responsible for the QC method transfers.



 


Qualifications

 


Education:



  • HS Diploma (required)

  • Science Degree (preferred)



Required:



  • 5 years Experience (with HS Diploma)

  • 3 Years Experience (with Bachelors Degree)

  • Packaging or Manufacturing Experience

  • Current Good Manufacturing Practises (cGMP)

  • Practical experience of instrumental methods of analysis (e.g. HPLC / FTIR / UV)



 


Preferred:



  • Experience of GMP review of analytical data, Quality Management System maintenance, quality auditing.

  • Experience of sampling, testing, reporting and trending of environmental monitoring data.

  • Packaging of Commercial Supplies

  • Quality Systems

  • GMP document auditing/reviewing

  • Training

  • Quality Auditing



 


Advancing human health requires exceptional people - your talent, experience and passion will be the perfect match.  Together we will make an exceptional difference to the health of countless patients all over the world and this is just the beginning. 


Lets be exceptional together


 


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 ADARequest@almacgroup.com to request assistance.


 

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Categories

  • Financial Services
  • Legal
  • Manufacturing / Production

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QC Team Leader

Almac Group, Inc
Audubon, PA 19403

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QC Team Leader

Almac Group, Inc
Audubon, PA
US

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