QA Specialist, Operations

Just is seeking highly-motivated Quality Assurance Specialist that desires to be part of a team focused on improving worldwide access to Biotherapeutics by supporting GMP plant operations. This individual will join the Quality team at Just with their primary responsibility being the execution of day-to-day QA responsibilities for GMP manufacturing, along with building and enhancing the quality assurance systems. The ability to work both independently and collaboratively with manufacturing, quality and facilities staff in a fast-paced and dynamic environment are essential to be successful in this position.

Responsibilities

• Provide Quality and Compliance oversight to support product manufacturing, release, and disposition operations to ensure compliance with early and late-stage clinical drug substance GMP manufacturing. This includes:
  • Review of manufacturing batch records, product/area changeover, and equipment use, maintenance logs.
  • Collaborate in the resolution of issues associated with manufacturing operations.
• Maintenance of quality systems and cGMP compliance by ensuring documentation is complete, accurate and executed in accordance with approved and effective standard operating procedures.
• Support and collaborate with manufacturing staff on the floor and with Quality assurance to understand the manufacturing process and relevant regulatory requirements to continuously improve operations.
• QA Review of QC data
• Provide QA oversight for product shipments, including cell banks, drug substance, and placebo
• Train and mentor Jr. staff as well as MFG staff on GMPs, GDPs, batch record review
• Author and revise quality related SOPs
• Provide input into project improvement efforts for the quality organization

Qualifications and Educational Requirements

• Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering or related life science field.
• 4+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.
• Familiarity with cGMPs and regulations applicable to the FDA and comparable international regulatory agencies to ensure compliance.

Preferred Qualifications

• Excellent verbal and written communication skills.
• Strong focus on quality and attention to detail.
• Possess effective task/time management organization skills.
• Previous experience working in Quality Assurance, Quality Control, or Drug Substance or Drug Product manufacturing

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.