Job description

Title: QC Specialist, Chem Data Review

Location: Norwood, MA

Type: Full Time/PERM

Schedule: Day Shift

Job Duties:

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, Osmolality, pH, 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.

Support the Support the investigation activities. Follow up and follow through the investigation closure to approve the final data in LIMS.

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.

Supports Troubleshooting of methods and equipment.

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.

Assist in regulatory, customer and internal quality audits that involve data review and data management.

Assist in test scheduling as necessary (e.g., when tests needs to be repeated based on data review) to meet the project timelines.

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.

Support authoring quality systems records such as deviations, change controls, CAPAs, OOS/OOT/OOE/LE, etc.

Establish and maintain a safe working environment

Minimum Qualification:

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

Strong attention to detail

Job Type: Full-time

Salary: $70,000.00 - $90,000.00 per year

Experience level:

• 2 years
• 3 years
• 4 years
• 5 years
• 6 years
• 7 years

Schedule:

• 12 hour shift
• Day shift

Work setting:

• In-person
• Manufacturing facility

Ability to commute/relocate:

• Norwood, MA 02062: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Experience:

• Manufacturing (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

Speak with the employer
+91 8400858336

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