Manufacturing Associate

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.

#LI-JC8

INDSCIC