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Quality Specialist - I (Assistant)

Lansdale, PA 19446

Posted: 03/06/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 618081 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 30-39.92/hr **salary will be commensurate with experience 

Job Description:


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

Qualifications:
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.
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About Lansdale, PA

Explore the vibrant job market around Lansdale, Pennsylvania, where exciting opportunities await you! Known for its historic charm, thriving arts scene, and close-knit community, Lansdale is the perfect place to grow your career. With easy access to Philadelphia and nearby attractions like the Montgomery Mall, Lansdale offers a perfect balance of urban amenities and suburban tranquility. Don't miss the chance to work in a town brimming with culture, from the acclaimed Lansdale Center for the Performing Arts to the diverse culinary scene featuring local favorites like the Stove and Tap. Start your job search today and uncover the endless possibilities that Lansdale has to offer!