Manufaturing Associate

100% onsite

Cambridge, MA (Kendall Square area)

29/hr on W2

multiple openings/shifts

Shift will either be Sun-Wed 7a-5pm or Wed- Sat 7a-5pm

OT is possible

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.

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

• 1+ years of experience in manufacturing production OR Bachelors' degree in an area of life sciences with 1+ year of experience in manufacturing production
• 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