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
- Manage the environmental monitoring program for all GMP areas on site.
- 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
- Responsible for the QC method transfers.
- 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
- Regulatory Inspections / Client Audits – Participate in the preparation for, and hosting of, regulatory and client audits of the Almac Pharma Services facility and operations.
- HS Diploma/GED required
- Bachelor’s Degree in Science preferred
- 5 years’ Experience (with HS Diploma) OR 3 Years (with Bachelor’s Degree)
- Packaging or Manufacturing
- Current Good Manufacturing Practices (cGMP)
- Practical experience of instrumental methods of analysis (e.g. HPLC / FTIR / UV)
- > 5 years’ Experience (with HS Diploma) OR > 3 Years (with Bachelor’s Degree)
- 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
- Quality Auditing
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 5,000 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 ADARequest@almacgroup.com
to request assistance.