The position is to support the ongoing commercial manufacturing effort in Wilmington. The position will be important in establishing and maintaining GMP-compliant manufacturing systems. They will work with production personnel to ensure documents and production records comply with GMP. They will play an integral part in ensuring the manufacturing systems and documents are GMP-compliant and audit and inspection-ready
MAJOR RESPONSIBILITIES
Work with Team Leaders and Supervisors to proactively identify and resolve GMP non-compliance issues in the Manufacturing group (Materials, Engineering, Production).
Write or revise (as required) SOPs and other GMP documentation supporting new or changed manufacturing processes in cooperation with appropriate manufacturing personnel.
Coordinate (expedite when required) the approval process for GMP documentation between Manufacturing, QA, QC, and Development
Review completed GMP documentation to ensure it is complete and accurate in preparation for product release.
Working in conjunction with Quality Assurance. establish an ongoing program of continuous improvement related to quality, compliance, and system efficiency.
Assure the resolution of deviation corrective actions, action items from Change Control systems, and any audit non-compliance items.
Conduct informal audits as requested by Management in support of investigations and process failures.
Participate in audits by internal as well as external groups and agencies.
Provide support in document preparation related to regulatory filings, validations, and new product introduction.
QUALIFICATIONS
Ability to work on and coordinate multiple projects in an orderly and efficient manner, consistently meeting established deadlines
Ability to work cross-functionally to meet company objectives
Strong knowledge of pharmaceutical manufacturing processes
Working knowledge of Good Manufacturing Practices (US and EU)
Strong oral and written communication skills
Ability to quickly understand detailed and complex processes
Team player committed to quality and working effectively with others, both internal and external to Alkermes
Motivated self-starter
Detail and results-oriented
Dependable, well-organized
Efficient with strong communication skills
Physical Requirements:
Occasional periods of repetitive motion.
Ability to gown in an aseptic manner for clean room operations.
Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
Ability to operate all types of production equipment
Ability to read, understand, and follow company SOP guidelines.
Ability to lift/move up to 50 lbs. Ability to team lift up to 100 lbs.
Ability to stand in steel-toed shoes for a minimum of 7 hrs.
EDUCATION AND EXPERIENCE
High School diploma or equivalent. Bachelor's degree in a scientific discipline or equivalent experience preferred.
Minimum 3 years experience in Quality Assurance or Manufacturing in the pharmaceutical or medical device industry