Biopharm Manufacturing Associate
1 month ago
Produce pharmaceutical components and products by following current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) within a cleanroom environment.
- 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.
Must be willing and able to work in rotating shifts, extended periods, and/or overtime when required.
Your Role:
- 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.
Background:
- 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.
About Alphanumeric Systems Inc.:
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
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