Description

• To provide QA oversight and approval of deviation, OOS, and change control records that have moderate to significant levels of complexity and/or novelty. Ensure records are properly initiated, investigated and resolved in accordance with established timelines.
• To provide QA oversight and approval of CAPA and EV records that have moderate to significant levels of complexity and/or novelty. Ensure CAPAs are initiated and resolved in a timely manner.
• Ensure escalation of deviations per procedures
• Identify efficiencies in the execution of the Deviation ad CAPA processes at TCF03 in a compliant manner
• Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues.
• Additional duties as assigned.
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

 
Basic Qualifications:

• Master's Degree and OR
• Bachelor's Degree and 2+ years' experience in the biological sciences or related field OR
• AA Degree and 4+ years' experience in the biological sciences or related field OR
• High School Degree and 5+ years' experience in the biological sciences or related field

 
Preferred Qualifications:

• Quality Control background in Analytical, Virological, and Microbiological testing
• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
• Ability to effectively negotiate and build collaboration amongst individuals
• Proficient in MS Word, Excel, Power Point and other applications.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

Key Skills

Education

Bachelor's or Master's degrees