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Quality Assurance Technical Lead
Souderton, PA
Job Description
Almac Group is currently seeking a Quality Assurance Technical Lead for our Souderton, PA location. The Quality Assurance Technical Lead is to act as the nominated Quality SME, providing support on specific local or global projects that require Quality input and expertise so that they are appropriately supported. In addition, the role will facilitate the implementation of new processes (or significant changes) within the Quality department and risk assessment activities specific to their area.
Responsibilities include but are not limited to:
- Act as the Quality SME on local or global projects to which you are assigned.
- Work closely with the sponsor, key stakeholders and project team
- Provide Quality input into the user requirements gathering and support the generation and approval of any associated change control, risk assessment and validation documentation
- Capture key decisions and provide regular updates to global Quality Management, highlighting any areas of concern and gain consensus on any discussion points requiring resolution
- Identify impacts and compliance risks and highlight to the project team
- Ensure deliverables to which you are assigned are completed in a timely manner
- Communicate updates to the wider Quality teams as required
- Facilitate the implementation of new processes or significant changes within the Quality department. In doing so:
- Work closely with Quality management (locally or globally) to define the scope of the initiative or change
- Lead the implementation exercise, track tasks, and monitor progress, providing clear visibility of key milestones and deliverables
- Facilitate the user requirements gathering and support the generation of process / data maps and the compilation and approval of any associated change control, risk assessment and validation documentation
- Work closely with department SMEs to generate / update SOPs
- Work closely with department OJT to develop educational material relevant to the changes being introduced
- Provide regular updates to local or global Quality Management, highlighting any areas of concern, gain consensus on any discussion points requiring resolution and report on project status
- Identify impacts and compliance risks and highlight to the project team * Highlight potential inter-dependencies and identify business readiness activities
- Facilitate effectiveness checks
Qualifications:
Required Experience / Education:
- Associates Degree
- 3+ years pharmaceutical experience with Associates Degree
- 1+ years pharmaceutical experience with Bachelors Degree
- Knowledge of Current Good Manufacturing Practices (cGMP)
- Working with Quality Systems
Preferred Experience / Education:
- Bachelors Degree with Science background
- Previous experience working under an established Quality System or within a Pharmaceutical /GxP environment
- Knowledgeable in GxP regulatory requirements
- Knowledge of Packaging/Labeling/Storing/Shipping Clinical Supplies
- Familiar with Clinical Trial Process
What can Almac Group offer you?
- Medical, Vision & Dental benefits from the 1st of the month following start date
- 20 days PTO per year, accrued monthly following start date
- 12 holidays per year
- Company paid Long and Short-term disability along with Life Insurance
- 401k company contribution
- 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 6,000 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.
Embracing diversity is at the heart of enhancing Almac Group's unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
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 to request assistance.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Associate Degree
Required Experience
3+ years
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