Job Description

Position Overview - Basic Functions & Responsibility

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, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor. The Quality Specialist performs review of process documentation/data for accuracy, completeness, and data integrity compliance. The incumbent may support the completion of batch disposition activities for release of product and may assist in conducting investigation of deviations. Additionally, the Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right the first time, and to ensure compliance with cGMPs and regulatory requirements.

• Becomes 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

• Collaborates with cross-functional team members to ensure batches are ready for release by appropriate due dates and executes the appropriate quality checks and SAP transactions required

• Responsible for routine auditing of GMP practices, documentation, and data

• Collaborates with cross-functional team members identifying and implementing continuous improvement initiatives and action plans

• 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

• Responsible for review/approval of new and updated Master Batch Records

• Performs review/approval of Qualification documents as needed

• Cross trains to support other functional quality areas including deviation management, documentation review, environmental monitoring, and qualification activities

• Provides support to internal audits and regulatory inspections as needed

• Fosters a customer service attitude within the functional area

• 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.

• 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 leadership skills coupled with good oral and written communication skills.

• 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.

• Experience in quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents.

• Experience with Aseptic gowning may be required.
• Demonstrated analytical aptitude, critical thinking skills and problem-solving skills.
• Demonstrated ability to upskill / coach others.
• Familiarity with GMP documentation review and/or shop floor auditing.
• Titers may be required.