- Responsibilities include, but not limited to operation and performance on equipment used in the manufacturing unit processes.
- Perform the weighing of manufacturing ingredients and the manufacturing of the intermediate formulations.
- Tasks include documentation, data entry, and computer software with compliant systems --Participation in continuous safety and environmental inspections
- Maintain continuous inventory control using computerized system.
- 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.
- Ability to lift up-to 20lbs.
- Additional duties and responsibilities as required.
- Associate degree in an area of life sciences with a minimum of 1 year of experience in manufacturing production or Bachelors' degree in an area of life sciences with 1 year of experience in manufacturing production preferred.
- 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.
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Biopharm Manufacturing Associate - Cambridge, United States - Alphanumeric Systems Inc.
Description
Alphanumeric is hiring a BIOPHARM MANUFACTURING ASSOCIATE to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.Produce pharmaceutical components and products by following current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) within a cleanroom environment.
Must be willing and able to work in rotating shifts, extended periods, and/or overtime when required.
Your Role:
Background:
Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. You may know us as a tech and communications firm established in 1979, but we also lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs.But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are)Apply today to join our family and Make Your Mark
