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location: North Billerica, Massachusetts
job type: Temporary
salary: $31.25 - 38.46 per hour
work hours: 9 to 5
Perform testing/review on incoming materials, finished products and stability studies in QC Laboratory. Provide support and technical expertise to ensure quality, compliance and efficiency in QC laboratory performance.
- 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.
- Perform routine, non-routine and more advanced lab testing in accordance with SOPs and cGMP guidelines. Perform verification and approval of data to ensure accuracy. Minimal supervision.
- May assist with ordering, responsible for some calibration and maintenance of laboratory equipment. May assist or write and execute protocols for procedural and instrumentation validations, and quality validation assessments (QVAs).
- Assist with audit readiness of laboratory area and act as SME during audits.
- Utilize a range of electronic systems such as LIMS, document/equipment management software, and ERP.
- Author, review and act as business owner for document changes; write/execute change controls, CAPAs, and utilize other quality systems.
- Resolve routine, non-routine and more advanced problems independently by utilizing appropriate resources. Provide problem solving and technical skills to support and/or lead the resolution and documentation of investigations.
- Represent Quality Control in team meetings and projects, providing technical perspective and expertise. Work on special projects as needed. Lead some continuous improvement efforts.
- Maintain and increase personal scientific, regulatory and compendial expertise, and contribute to team objectives. Extensive knowledge of industry practices for assigned area.
- Extensive knowledge in specialized functions. A wide and comprehensive acquaintance with, and understanding of, both general and specific aspects of the job and their practical application to complex problems and situations ordinarily encountered. Demonstrates flexibility to handle changing priorities without impact to other projects. Minimal supervision required. Follows established procedures.
- Team player who can work independently with quality and attention to detail. Strong communication skills both oral and written, professional conduct. Effectively and efficiently participate in assigned tasks in a quality manner. Solid interpersonal skills, ability to take a lead role and interact with a diverse group of individuals at various levels (including key-stake holders, inter-organizational and outside contacts such as vendors or CMO representatives). Represents the organization in providing solutions to difficult technical issues.
- Actively promote safety rules and awareness. Reports and takes 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, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.
- Typically requires 5-8 years with a BS degree in a related scientific discipline (e.g. chemistry, biology) or equivalent combination of education and previous relevant experience in the pharmaceutical industry, related GMP environment, or equivalent. Previous analytical chemistry including HPLC, GC, NMR, and AA experience preferred.
- Routinely scheduled work, and/or overtime work required on evenings, weekends, and/or holidays, including during adverse weather conditions. Some non-routine travel may be required.
- Work with (or in proximity to) potentially hazardous chemical materials and must be able to lift/move materials, e.g. gas cylinders, ~10-20 lb bottles of chemicals, and ~25 lb. HPLC waste containers.
skills: Quality Assurance, GLP (Good Laboratory Practice), 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.