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Form of workExperience with visual inspecting components like primary packaging components (vials) for defects is required. Quality assurance and quality control background in a manufacturing environment is a good fit for this role. Not looking for lab scientist
Education: Associate's Degree in Biology, Biochemistry, Chemistry, with 3+years of relevant experience. Will also consider someone with BA/BS/MS in Biology, Biochemistry, Chemistry with 2+ years of relevant experience. Required experience: Experience with sample retention, sample management, component inspections with in GMP and GDP. Nice to have experience with visual inspecting components like primary packaging components (vials) for defects. Preferred: Operations, Quality Control, Quality Assurance and/or cGMP experience. GENERAL EXPERTISE: Requires knowledge and experience in own discipline; still acquiring higher-level knowledge and skills Builds knowledge of the company, processes, and clients and/or customers Solves a range of straightforward problems Analyzes possible solutions using standard procedures Receives a moderate level of guidance and direction Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals Effective communications (oral/written) and interpersonal skills are necessary. Physical Requirements Required to work in cold environments Lifting 20-30 pounds Ability to sit, stand and move within workspace for extended period. Note: 1year assignment with possibility of extension. M-F(8a-5p). 100% onsite role.
Responsibilities:
Quality specialist is responsible for inspecting and sampling primary packaging components delivery and document coordination that supports VMF 101/102 production; he/she must adhere to regulatory, global and site policies and procedures governing product release. Primary Responsibilities: Ability to work independently and as a member of the team. Contributes to the performance and results of the Sample Control Team Requires knowledge and experience in own discipline; still acquiring higher-level knowledge and skills Analyzes possible solutions using standard procedures Receives a moderate level of guidance and direction Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals Perform visual and dimensional inspections. Functional Expertise Understands and applies regulatory and compliance requirements relative to their role Understands the fundamental business drivers for the company and uses this knowledge in own work. Basic conceptual knowledge and practices associated with inspection Ensure the Chain of Custody of samples. Storage, receipt, sampling, visual examinations, complaint inspections and discard of samples. Assist in coordinating sister site(s) retention examination requests for complaint investigations for batches located at the Durham site. Transfer retention samples to market authorization storage temperatures Document results of inspection onto inspection record and global laboratory information system Meticulous attention to detail and possess good organizational skills Assist in investigations, which includes interactions with vendors or our Company internal teams to resolve issues associated with retention samples. Development of metrics and process improvements for disposition prioritization and lead time reduction Participate in process improvement or learning events, as guided or approved by Quality management Participate in GEMBAs and safety walkthroughs Replies to standard requests from clients and/or customers Housekeeping and documentation in cleaning logs
