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Manufacturing Associate
- Contract
- Biological Sciences, Medicinal Chemistry, Pharmacology
- United States
Proclinical is seeking a Manufacturing Associate for a global biopharmaceutical company located in Cambridge, MA.
In this role, you will produce pharmaceutical components and products by following current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) within a cleanroom environment.
Must be eligible to work in the US.
Job Responsibilities:
- Follow aseptic procedures and good documentation practices.
- Follow production schedule and prepare materials for production runs.
- Prepare solutions per production schedule.
- Cleaning, operating, and maintaining GMP equipment.
- Prepare equipment for processing by performing cleaning-in-place (CIP) and cleaning-out-of-place (COP), as necessary.
- Perform equipment inspections to ensure readiness and preventative maintenance, as needed.
- Operate and monitor GMP equipment, adjust equipment controls, perform actions as specified by production batch records (BPRs), adhere to aseptic behaviors, and maintain a safe and clean work environment by following cGMPs.
- Document production by completing forms, reports, logs, and records of equipment batches.
- Maintain up-to-date training records.
- Perform cleaning of production suites daily and as necessary.
- Create and edit production records and documents, as necessary.
- Work with environmental monitoring to maintain a clean and safe work environment.
- Additional duties and responsibilities as required
Skills and Requirements:
- 2+ years of experience in manufacturing production OR Bachelors' degree in an area of life sciences with 1+ year of experience in manufacturing production
- Must be comfortable working with gowning prep (full gown and goggles)
- Effective oral and written communication skills required
- Experience or understanding of pharmaceutical development preferred
- Knowledge of cGMP, GDP, USP, and FDA quality guidelines and regulations preferred
- Process organizational skills to ensure production batch completeness preferred
- Ability to lift up-to 20lbs
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at +(1) 267-846-2026 or j.cerchio@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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