Almac Group is currently seeking a QA Team Leader for our Souderton, PA location. The QA Team Leader will be responsible for assessing and improving Almac Clinical Services GMP Compliance by performing review and approval of GMP documentation at any Almac Clinical Services (ACS) site, in accordance with the principles of GMP and internal procedures. This position will involve the supervision and development of an assigned team. The position will be required to promote a quality culture by maintaining Almacs’ quality management system and driving continuous improvement while ensuring adherence to cGMP, Almac SOPs and Policies.
Responsibilities include but are not limited to:
- Manages the activities of the QA Auditors and QA Auditors with RP.
- These staff are responsible for reviewing documentation, at any ACS site, and ensuring compliance with the principles of GMP, customer-approved procedures, and Almac SOPs. Examples of these tasks include:
- Batch Document Review
- Release of Distribution Orders
- QA Helpdesk Activities
- Assist team with resolution of batch record queries and respond to customer queries for executed batch records.
- Assist in the hiring of Quality Assurance personnel.
- Train, Mentor and provide support to personnel in the team providing advice and guidance in order to build on their competence and experience.
- Monitor output, quality and consistency of reporting staff and be accountable for their performance, ensuing departmental Key Performance Indicators (KPIs) are met.
- Manage Resources for routine tasks without affecting departmental KPIs.
- These staff are responsible for reviewing documentation, at any ACS site, and ensuring compliance with the principles of GMP, customer-approved procedures, and Almac SOPs. Examples of these tasks include:
- Continuously consider opportunities for business improvement and be forthcoming with ideas/suggestions regarding process simplification and improved compliance. Be proactive regarding implementation of such through the generation/revision of SOPs and ensure collaboration with global counterparts, at all ACS sites, in order to gain agreement.
- Complete task by drafting and road testing processes, ensure global consensus is obtained where needed and finalizing and routing the procedure for approval.
- Additionally provide department and/or site training where required, this includes taking on the role of a “Key Trainer” when necessary.
- Review and approval of GMP Documentation, from any ACS site, as detailed in the relevant procedures. Examples of such documentation are as follows:
- Change Requests, including computerized systems, receiving, and plant (facility/equipment).
- QI/TQ reports
- Validation paperwork
- Global Distribution Instructions for Just In time (JIT) Labelling operations
- Risk Assessments and associated forms
- Serves and interacts as a key contact for Project Services staff, Operations staff, and customers in both the mitigation of quality issues or technical queries by identifying, resolving or escalating the issue to prevent delays in the release of documentation as well as overall quality support.
- Participate in audits and meetings as needed
- Serve as a site contact for key accounts, supporting the KAM as needed
Qualifications:
Required Experience / Education:
- Bachelor’s Degree or Associates Degree and 3 years Quality Assurance experience at Almac Clinical Services or HS Diploma and 6 years Quality Assurance experience at Almac Clinical Services
- 6 years’ experience specific to Almac Clinical Services Quality Assurance (with HS Diploma)
- 3 years’ experience specific to Almac Clinical Services Quality Assurance (with Associates Degree)
- Packaging or Manufacturing
- Current Good Manufacturing Practices (cGMP)
- Quality Systems
- GMP document auditing/reviewing
- Quality Auditing
Preferred Experience / Education:
- BS in Science
- 7 years’ experience specific to Almac Clinical Services Quality Assurance (with HS Diploma)
- 4 years’ experience specific to Almac Clinical Services Quality Assurance (with Associates Degree)
- 2 Years (with Bachelor’s Degree)
- Packaging of Clinical Supplies
- Delivering Training
- Managing of Staff
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.
