Quality Operations Specialist

About the role

Almac Group is seeking a Quality Operations Specialist for the Audubon, PA location. The role provides and ensures quality support to onsite packaging and warehousing operations, ensuring compliance with current GxP’s.

Responsibilities

• Verify and ensure Critical Process Parameters/Equipment Set-up/Challenges prior to start-up of equipment/operation.
• Verify and ensure inspections/AQLs are correctly set-up and executed by Production to established quality criteria for each batch.
• Review and approve ‘first off’ samples produced during setup of Packaging operations.
• Review and approve finished good sample inspection.
• Review in-process and executed batch records on the Production floor to ensure compliance with Master documentation and GxPs and to meet turnaround times.

Qualifications

Required Experience / Education:

• Associate’s degree in a Scientific discipline
• 5 years in Pharmaceutical QA, QC or Operations (with associate’s degree) OR 3 Years in Pharmaceutical QA, QC or Operations (with bachelor’s degree)

Required Knowledge:

• Experience with Microsoft Office applications and quality management systems
• Demonstrated ability for effective communication, teamwork, and problem‑solving skills
• Adequate emotional intelligence to handle a variety of situations professionally and in accordance with regulatory compliance
• Experience within a manufacturing, packaging, and laboratory environments and associated equipment

Preferred Experience / Education:

• Bachelor's Degree in a Scientific discipline
• Experience with the generation, execution, and review of quality documents in a commercial pharmaceutical packaging facility.

Preferred Knowledge:

• Knowledge of the regulatory requirements and industry standards for pharmaceutical packaging processes

Benefits

• 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 as well as one day for Annual Diversity Day
• Company paid Long and Short‑term disability along with Life Insurance
• 401k company contribution
• Professional development programs/ continuous learning opportunities