**PLEASE NOTE THIS IS A CONTRACTOR/TEMPORARY ROLE** Ideal candidate is not currently working.
Amicus Therapeutics Inc. is seeking an Associate, Quality Operations with a working knowledge of biopharmaceutical manufacturing. Reporting to the Manager, Quality Operations and Product Disposition. The Associate will provide quality reviews of manufacturing batch records and associated supporting documentation for the production of clinical and commercial products. The Associate will be responsible for supporting departmental quality initiatives and maintaining Amicus Quality standards.
Roles and Responsibilities
- Review and approval of master batch records
- Review and disposition of executed batch records
- Assurance that final release specifications have been met
- Maintaining a batch record comments log and communicating with vendors regarding batch record questions and corrections
- Confirming all deviations and resulting investigation reports have been closed out prior to dispositioning batch records
- Confirming all change control reports have been closed out prior to dispositioning batch records
- Collecting and organizing all required documentation associated with batch production necessary for release by the Qualified Person
- Maintaining a batch record disposition schedule and contributing to batch record summary database
- Any other duties as requested by management that is applicable to the role
- BS or equivalent and a minimum of 3 years of experience in the pharmaceutical/biotech industry
Professional Work Experience Requirements
- Must have at least 1-year experience in the review and disposition of manufacturing batch records
- Working knowledge of FDA and EMA GXP regulations and ICH guidance documents
- Experience communicating with vendors in the dispositioning of batch records
- Experience in the manufacture of biopharmaceutical drug substance and drug product
- Experience with biologics manufacturing is preferred
- Experience in final formulation and packing of biologics and small molecules preferred
- Experience with small molecule manufacturing is a plus
- Demonstrated alignment with Amicus Mission Focus Behaviors
- Passion for rare disease and patient focused
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.
Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.
Job Types: Full-time, Contract, Temporary
Pay: $30.00 - $40.00 per hour
- 8 hour shift
- Are you currently employed?
- Batch Review: 1 year (Required)
Work Location: Remote