QC Analyst
About The Position
The Quality Control (QC) Analyst will act as a team member of the Quality Control department to support production of in-process, drug substance, drug product, raw materials, and stability lots for customers. Will perform laboratory testing in a cGMP environment and understand the science and compliance needs of the business. This role actively participates in continuous improvement to maintain company’s right to operate, supply to patients and cost effectiveness. A QC Analyst applies job skills, company policies, and procedures to complete a variety of tasks. They will work on assignments that are both routine and semi-routine in nature where ability to recognize deviation from accepted practice is required and works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
Requirements
- Degree/Diploma in a relevant Science field, or equivalent experience.
- Relevant work experience, with a strong preference for GMP/Lab experience in a biotech or medically related field.
- The ability to work comfortably and effectively in a production floor setting.
- Adaptable to receiving detailed instructions and performing assigned duties according to specified procedures.
Responsibilities
- Perform a broad variety of basic lab activities and prepare basic and complex reagents to consistently support laboratory operations and testing workflows.
- Review GMP documentation and maintain a continuous state of inspection readiness to ensure strict regulatory compliance.
- Perform routine lab maintenance and equipment qualification/maintenance to guarantee system reliability and data accuracy.
- Identify and recommend solutions to potential procedural and process system gaps, actively participating in teamwork for process improvements.
- Recognize deviations from accepted practices while working on semi-routine assignments and problems of limited scope.
- Improve laboratory inventory processes and use laboratory computer systems and Microsoft Suites to enable efficient operations.
- Coordinate with testing analysts and manage competing priorities with instruction to support broader team operational activities.
Benefits
- Performance-related bonus
- Medical, dental and vision insurance
- 401(k) matching plan
- Life insurance, as well as short-term and long-term disability insurance
- Employee assistance programs
- Paid Time Off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
