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Job type: Contract

Discipline: Biological Sciences, Medicinal Chemistry, Pharmacology

Location: 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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