Quality Assurance Specialist implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist audits and reviews quality data according to existing procedures. Documents results in required format. Additionally, Quality Assurance Specialist requires a bachelor's degree or equivalent. Typically reports to a manager or head of a unit/department. The Quality Assurance Specialist work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Assurance Specialist typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Specialist, GMP QA
Quality Assurance
Job Description
Reporting to the Manager, GMP Quality Assurance, the Specialist, GMP QA has experience in cGMP (Code of Federal Regulations 21CFR Parts 210, 211 and Part 11, EU GMP), as well as ICH Quality Guidance’s (Q9, Q10, Q11) and both USP and EP Pharmacopeia. The Specialist, GMP QA will have demonstrated ability to work in a laboratory setting and experience interfacing with customers on quality related matters.
Key Responsibilities
The Specialist, GMP QA is responsible for assisting in the maintenance and improvement of the Quality System to meet compliance with GMP requirements. The Specialist, GMP QA will own one or more of the following Quality processes: Internal Audits, Vendor Qualification and Management, Change Control, Investigations and CAPA, Risk Management, or others as assigned. The role has shared responsibility for reviewing and approving data prior to it being submitted to clients. The role also has shared responsibility for the document control processes in MasterControl, including the review and approval process for documents.
Qualifications
About Prolytix
Prolytix, formerly Haematologic Technologies (HT), is a leading provider of analytical and bioanalytical services to support the research, development, and commercialization of large molecule biotherapeutics and reagents for coagulation research. Prolytix builds on 30 years of expertise to identify and solve the most complex large molecule challenges. Prolytix’s expertise in protein biochemistry supports biotherapeutics from discovery through commercial release, with biopharma services all performed in fully compliant, FDA-inspected GMP facilities. The company also provides expertise in plasma proteins, hemostasis, and blood coagulation and is a leading global supplier of coagulation research reagents (plasma proteins and antibodies), custom formulated IVD/POC device reagents, as well as customized blood collection tubes to support clinical trials. Visit us at goprolytix.com.
Job Type: Full-time
Pay: $55,000.00 - $75,000.00 per year
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Work Location: In person