Quality Analyst II

  • location: North Billerica, MA
  • type: Permanent
  • salary: $42,000 - $58,000 per year
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job description

Quality Analyst II

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

 
location: North Billerica, Massachusetts
job type: Permanent
salary: $42,000 - 58,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Perform testing on incoming materials, finished products and stability studies in QC Laboratory. Work in both lab and warehouse areas. May be trained as fork truck operator.

  • Perform routine QC testing in accordance with SOPs and cGMP guidelines. Some supervision required.
  • Perform verification of data to ensure accuracy. Perform approval upon discretion of supervisor.
  • Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment.
  • Utilize a range of electronic systems such as LIMS and document/equipment management software.
  • Author SOP changes; participate in change controls, CAPAs and other quality systems.
  • Resolve routine problems by utilizing appropriate resources. Assist in investigations.
  • May assist on special projects as needed. Help with continuous improvement.
  • Train on and maintain knowledge of current regulatory requirements and relevant internal procedures.
  • Work independently and as a team player with quality and attention to detail. Good communication skills both oral and written. Effectively and efficiently participate in assigned tasks in a quality manner.
  • Actively promote safety rules and awareness. Report and take initiative to correct safety & environmental hazards. Work with potentially hazardous chemical, radiological and/or biological materials on a daily basis. Demonstrate good safety practices at all times including the appropriate use of protective equipment.
  • Actively demonstrate the values of accountability, quality, efficiency, customer service, collaboration, and safety.
  • *In case of absence the "Reports to" Manager above or a peer incumbent will function as a backup for this position.
 
qualifications:
  • Typically requires 1-3 years of previous experience in the pharmaceutical industry, related GMP environment, or equivalent. Previous experience preferred.
  • Requires a BA/BS degree in a related scientific discipline (e.g. chemistry, biology) or equivalent combination of education and experience.
  • Testing also includes visual inspections, dimensional verifications and analytical testing.
  • Additional materials tested include components, printed materials and chemicals.
  • Group is additionally responsible for raw materials, chemical sampling, the release of materials, retaining inventory, and stability setup and pulls.
  • Some non-routine travel may be required.
  • Flexibility with scheduling requirements-may include shifts, overtime, weekends and holiday coverage, including during adverse weather conditions.
  • Must be able to lift 50 lbs.
 
skills: Quality control, SOP, CAPA, Microbiology, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System
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.

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