The QUALITY CONTROL INSPECTORs responsible for making sure all purchased, in-process, and the completed product is manufactured according to specifications. This includes: configuration, dimension, aesthetics, contamination, surface finish, packaging/ labeling, and material properties to meet the company's quality and Good Manufacturing Practice (GMP) requirements.
Experience using measurement tools like caliper, micrometer, go/no-go gages, etc.,
The QC specialist performs visual, dimensional, and functional inspections of raw material, components, in-process, and final product based on documented specifications (i.e. drawings, procedures work instructions, etc.) with a high degree of accuracy
Experience updating material and product specifications, incoming and in-process inspection forms as part of Document Control activities
Manage quality material/product shipping and provide acceptable paperwork to meet the company's raw material quality requirements
Reviews production batch records (MBRs) for accuracy and completeness to approve intermediate products for use in production. Report all deviations and ensure their resolutions prior to issuing approvals
Record inspections in our quality database
Transacts parts in inventory control system
Initiates nonconformance reports (NCRs) to prescribed procedures
Effectively supports and follows policies and procedures
Conducts spot-check inspections/audits of production operations
Communicates quality issues to QA Management in a timely manner
QUALIFICATIONS
Associate's degree in a Biology, Chemistry, Life Sciences, or other related technical fields
1-2 year of quality experience in a regulated environment (i.e. medical device, aerospace, defense, pharmaceutical, etc.)
Familiarity with ISO 13485 or 21 CFR 210, 220 and 600 (best practices for biologics and/or drug products) is preferred.
Ability to carry out instructions furnished in written, oral, and/or diagram formats
Ability to discern the acceptability of product, based on specifications, standards, and training