Quality Specialist
Location: 770 Sumneytown Pike, West Point, PA Pay Rate: $39/HR
Required Education:
Bachelor's degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.
Required Experience and Skills:
Minimum 1-2 years of relevant post-degree work experience in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting. Evidence of good oral and written communication skills. Familiarity with GMP documentation review. Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area. Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.
Preferred Experience and Skills:
Experience in quality systems, authoring and approving GMP documents. Experience with Aseptic gowning may be required. Demonstrated analytical aptitude, critical thinking skills and problem-solving skills. Titers may be required.
Responsibilities:
The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Batch Record Review Quality Manager, the Quality Specialist ensures quality, and compliance of products manufactured by the functional area and adherence to Good Manufacturing and Documentation Practices. Primary Activities: Fully trained in relevant Standard Operating Procedures (SOPs), Work Instructions (WIs) and competency-based activities. Learns cGMPs, the manufacturing process, and our company quality systems, including SAP, GLIMS and electronic logbook, laboratory data, and batch record platforms. Provides presence on the shop floor to support compliance and data integrity. Reviews production documentation such as batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors. Reviews and approves new and updated SOPs and Controlled Job Aids. Actively participates in the Tier process and uses this forum to make concerns visible and to partner with the functional area on resolution. Fosters a customer service attitude within the functional area.
