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Quality Control Analyst
3 months ago
Job Responibilities:
- Conduct microbiological, molecular, and cell culture assays for both in-process and final product samples.
- Assist in transferring methodologies from other groups and may manage complex equipment.
- Author reports, Standard Operating Procedures (SOPs), and other documentation for quality testing and equipment.
- Provide training and technical leadership to less experienced staff members.
- Participate in or conduct laboratory investigations and address non-conformance deviations.
- Perform finished product reviews and oversee lot releases.
- Potentially manage departmental projects.
- Participate in the execution of corrective and preventative action plans, as well as initiate and follow through with change controls.
- Exercise judgment and decision-making skills to solve problems.
- Communicate with other departments and external contacts to resolve technical issues.
- Perform other duties as assigned.
- Demonstrate honesty and respect in all interactions.
- Act as role models for fellow employees and business partners by behaving responsibly, fairly, and honestly, and exercising sound judgment in job performance.
Qualifications:
- Bachelor’s Degree with a minimum of 5+ years of relevant industry experience in a CGMP lab environment, or equivalent.
- Master’s Degree with a minimum of 3+ years of relevant industry experience in a CGMP lab environment, or equivalent.
- Proven experience as a technical leader in a strong team environment and the ability to work independently to balance short and long-term project objectives successfully.
- Experience with Deviation Management and Change Control.
- Proficiency with complex analytical methods, such as PCR-based methodologies or cell culture techniques.
- Experience with assay/equipment validations and transfers.
- Excellent verbal and written communication skills.
- Strong technical writing and investigational abilities.
