Manufacturing Compliance Specialist

2 months ago

Wilmington, United States Alkermes Full time
Job Description

POSITION SUMMARY

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


About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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