Biopharma Manufacturing Associate

Job Summary

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.

location: Cambridge, Massachusetts

job type: Contract

salary: $42.00 - 45.48 per hour

work hours: 3 to 11

education: Associate

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.
• Ability to lift up-to 20lbs.
• Additional duties and responsibilities as required.
  
  

Qualifications

• 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.
  
  

Required

• HS Diploma or equivalent is required with several years of experience, OR Associates degree with a couple years of experience, OR Bachelor's degree with no experience
• Safety and quality mindset is very important
• Common sense
• Punctual and showing up on time / at all
• Computer literacy, navigating computer work
• Ability to work well with others, specifically in pairs and ability to work independently
  
  

Preferred

• Associate or Bachelor's degree in biological/life science, but not required
• cGMP experience, if no bachelor's degree
• Background in science or manufacturing
• Manufacturing experience is acceptable but Pharma experience is preferred- if sending candidates with packaging experience it should be more GMP or documentation.
• Cleanroom experience
  
  

skills: SOP, GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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