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Bioassay Review Specialist (QC Microbiology)

Employer
Connexion Systems & Engineering, Inc.
Location
Norwood, Massachusetts, US
Salary
Competitive
Closing date
May 16, 2024

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
Job DescriptionJob Description
Job Title: Reviewer I, Bioassay
Location: Norwood MA
Pay Rate: $45-52/hr

We are seeking a Quality Control Chemistry Data Review Associate I based at Norwood laboratory, MA sites. The individual in this role will focus on Release, Stability and In Process data review and reporting for clinical and commercial products. This role may support special projects as needed.

Here's What You'll Do:

· Performs routine analytical chemistry data review and reporting of data generated through the laboratory tests including HPLC, UPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, Spectramax Plate Reader, Osmolality, pH, KF, appearance, etc.

· Perform data review in LIMS and in paper worksheets if applicable.

· Ensure all laboratory tests are performed correctly and meet cGMP and GDP compliance requirements.

· Communicate the OOS/OOT/OOE/LE/Deviation cases to quality event investigation team promptly to ensure the Chemistry lab comply with investigation/deviation SOP procedures.

· Ensures timely and successful execution of the assigned data review and data management task.

· Interact with other analysts when corrections are identified as part of the data review process.

· Performs data entry and supports trending and analysis as applicable.

· Perform and/or support Certificate of Analysis generation as needed.

· Participates in project meetings to provide status updates to stakeholders.

· Provides prompt communication of risk and mitigation for all data management related deliverables.

· Work on continuous improvement for data review requirements and processes to ensure delivery of highest quality of data.

· Complete and maintain cGMP documentation (electronic and Hard Copy) for laboratory raw data packets.

· Establish and maintain a safe working environment

Here's What You'll Bring to the Table:

· Minimum education required: Bachelor's degree in a relevant scientific discipline, preferred in Chemistry.

· Minimum experience required: 2-5 years in a laboratory setting with focus in pharmaceutical QC analytical chemistry
Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

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