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location: North Billerica, Massachusetts
job type: Permanent
salary: $42,000 - 58,000 per year
work hours: 9 to 5
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.
- 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.