The company is looking to ensure its products meet world-class standards through meticulous quality assurance processes.
Requirements
- Proficient in the requirements of ISO 9001:2015
- Proficient in the requirements of ISO 13485:2016
- Proficient in the requirements of 21 CFR 820
- Knowledge of cGMPs and LGC Biosearch policies and procedures
- Strong mathematical skills: Ability to add, subtract, multiply, and divide all units of measure, using whole numbers, common fractions, and decimals
Responsibilities
- Review of batch production records for completeness and compliance with cGMPs and LGC Biosearch policies and procedures
- Review of analytical records and supporting documentation to ensure compliance with cGMPs and LGC Biosearch policies and procedures
- Perform QC data review for batch record in-process and final QC approval
- Perform routine document control activities including creation and/or revision, processing, routing and review of all controlled documents
- Assist in all dispositions as a result of the Material Review Board
- Assist with Internal Quality audits of internal departments as necessary
- Work with various departments to set up appropriate documentation to improve efficiency and accuracy
Other
- AA, AS in Chemistry, Biochemistry, Biological Sciences, or a similar scientific field, or an equivalent combination of education and experience
- A minimum of 1 year of experience is required
- 2+ years of experience in a diagnostics or medical device environment (preferred)
