: QC Biotechnician I Job Responsibilities
Completes timely and efficient quality control laboratory testing for intermediate control and release of final product. Maintains documentation, equipment and laboratory space in compliance with GMP & ISO 13485 standards. Assists in identification and implementation of continuous improvement initiatives. QC Biotechnician II Responsibilities and Duties:
- Perform QC testing as per production schedule with strict adherence to Manufacturing Batch Records and SOPs. Completes documentation in a timely manner and develops new and/or improved methods and SOPs for product QC testing.
- Maintain laboratory and equipment according to internal procedures and GMPs.
- Supports internal investigations, customer, and supplier audits.
- Maintains and analyzes quality records and logs to identify anomalies and trends, and monitor completion of action items.
- Performs verifications of the QC work and documentation of peers as needed.
- Utilizes systems for tracking project status and results of testing. (SAPA, Intelex, etc.)
- Generates Certificate of analysis for each product to be released based on internal and customers specifications.
- Responsible for investigating non-conforming issues within QC department.
- Perform additional job duties necessary within manufacturing areas as assigned.
: (Knowledge, Skills and Abilities: Education, Experience, Job Skills, Equipment Skills, and Certifications)
- BS/BA in a life sciences discipline (i.e. Biochemistry, Medical Technology, Biology).
- Minimum of 2 years laboratory testing/QC experience working in a regulated environment.
- Working knowledge cGMP & ISO 13485.
- Working knowledge of biological processing and QC methodology (e.g. ELISA, RID, HPLC, Clinical Analyzers, SDS-PAGE, IEF, IHC, Isotype).
- Proficient with general laboratory methods, equipment and aseptic technique.
- Computer literacy to include Office products.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.