QC Technical Transfer Specialist
Karwell TechnologiesPortsmouth, NH
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Overview
Remote
On-site
Job Description
Job Summary
The Quality Control Analyst supports laboratory operations by performing analytical testing, reviewing laboratory data, supporting method transfers and validation activities, and ensuring compliance with GMP and Data Integrity requirements. This role works within a pharmaceutical or biotechnology quality control laboratory and collaborates with cross-functional teams to support product quality and regulatory compliance. Responsibilities:
- Perform analytical testing for raw materials, in-process samples, finished products, stability samples, and lot release testing.
- Execute analytical methods following GMP guidelines.
- Support analytical method transfers between laboratories.
- Assist in method validation and verification activities.
- Review laboratory data for accuracy and completeness.
- Investigate laboratory deviations and Out-of-Specification (OOS) results.
- Prepare and maintain GMP documentation.
- Support Change Controls, CAPAs, Deviations, and Investigations.
- Perform root cause analysis and implement corrective actions.
- Maintain laboratory instruments and equipment.
- Utilize laboratory software including LIMS, Empower, SoftMax Pro, SoloVPE, and TrackWise.
- Support software validation and CSV activities.
- Ensure compliance with cGMP, GDP, ALCOA+, and Data Integrity principles.
- Participate in audits and inspection readiness.
- Collaborate with QA, Manufacturing, Validation, and Engineering teams.
- Train laboratory personnel on procedures and systems when required.
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FAQs About QC Technical Transfer Specialist Jobs at Karwell Technologies
What is the work location for this position at Karwell Technologies?
This job at Karwell Technologies is located in Portsmouth, NH, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Karwell Technologies?
Employer has not shared pay details for this role.
What employment applies to this position at Karwell Technologies?
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