Senior Specialist, Quality Assurance

Responsibilities

• Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM.
• Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).
• Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities.
• Engages and collaborates with operations department to drive quality system and CGMP requirements.
• Performs product release activities per CGMP requirements.
• Maintains monitoring of CAPA in investigations and closes when completed or escalates (if necessary).
• Performs aseptic review of the site with operations and documents results.
• Reports quality system issues to the RQM and others as necessary.

Qualifications

• 2-4 years of experience, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred
• Proficiency with MS Excel and MS Word
• Interpersonal skills
• Attention to detail
• Prior experience working nightshift, preferred
• Prior experience maintaining a filing system, preferred
• Project management, preferred
• Prior experience in a cGMP environment, preferred

Benefits

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Paid parental leave
• Healthy lifestyle programs