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location: North Billerica, Massachusetts
job type: Permanent
salary: $68,000 - 74,000 per year
work hours: 9 to 5
- Perform routine QC testing in accordance with SOPs and cGMP guidelines. Independent worker.
- Perform verification and approval of data to ensure accuracy.
- 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, review and potentially act as the business owner for SOP changes; participate in change controls, CAPAs and other quality systems.
- Resolve routine and advanced problems by utilizing appropriate resources. Provide problem solving skills to support investigations.
- Write and execute protocols for procedural and instrumentation validations.
- Work on special projects as needed. Lead some continuous improvement efforts.
- Represent Quality Control in team meetings and projects.
- 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 5-8 years of previous experience in the pharmaceutical industry, related GMP environment, or equivalent. Previous analytical chemistry including HPLC, GC and AA experience preferred.
- Requires a BA/BS degree in a related scientific discipline (e.g. chemistry, biology) or equivalent combination of education and experience.
- Some non-routine travel may be required.
- Flexibility with scheduling requirements-may include shifts, overtime, weekends and holiday coverage, including during adverse weather conditions.
skills: Quality control, HPLC, SOP, Analytical Chemistry, 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.