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location: North Billerica, Massachusetts
job type: Temporary
salary: $20 - 26 per hour
work hours: 9 to 5
- Perform testing on incoming materials, finished products and stability studies in QC Laboratory. May cross train on working with radioactive materials.
- Perform routine and non-routine analytical chemistry QC testing in accordance with SOPs and cGMP guidelines. Troubleshoot analytical problems and execute solutions. May also perform advanced testing. Minimal 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. May participate in advanced LIMS applications.
- Author and review SOP changes; participate in change controls, CAPAs and other quality systems.
- Resolve routine and more advanced problems by utilizing technical knowledge and appropriate resources. Provide problem solving skills to support investigations and root cause analysis.
- Participate in protocols for method and instrumentation validations.
- Work on special projects as needed. Participate in technical transfer qualifications. Contribute towards 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 company values of accountability, quality, efficiency, customer service, collaboration, and safety. Also, demonstrates appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.
- *In case of absence the "Reports to" Manager above or a peer incumbent will function as a backup for this position.
Area Specific Requirements
- Perform a wide variety of analytical methods ranging from basic to complex using HPLC, GC, AA, NMR, FTIR, UV, TOC, polagraphic analyzer, DSC, KF, autotitrator instrumentation and compendial wet chemistry methods.
- Group is additionally responsible for the reference standard program. Additional materials tested include raw materials (chemicals), reference standards and solutions used in manufacturing.
- Requires a BA/BS degree in Chemistry
- Typically requires 3-5 years of previous experience in the pharmaceutical industry, related GMP environment, or equivalent. Previous analytical chemistry including HPLC, GC and AA experience preferred.
skills: Quality control, HPLC, SOP, CAPA, 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.