Overview
Quality Assurance Specialist Jobs in San Antonio, Texas, USA at Evestra, Inc.
Evestra, Inc. is looking for a Quality Assurance Specialist in San Antonio, TX.
This local job opportunity with   is live since :14:38.
Our Company:
Evestra, Inc. is an emerging biopharmaceutical company that focuses on developing and commercializing women’s healthcare products. Based in San Antonio, Texas, Evestra’s mission is to improve the health and well-being of women around the world through innovative technologies and products.
DUTIES AND RESPONSIBILITIES:
Performs and documents GLP, cGMP, and internal audits; audits documentation associated with drug substances and drug products, stability programs, complaints, and related systems.
Prepares audit reports and performs follow-up to obtain resolutions that are compliant with regulations and satisfactory to all parties.
Identifies in-house quality issues.
Leads product nonconformance investigations.
Prepares impact assessments for process and procedural deviations.
Researches and assists in interpretation of regulations that are relevant to company’s operations.
Maintains auditing schedules.
Participates in vendor certification programs.
Maintains quality assurance databases, reports, and files.
Assists in performing audits of external raw material vendors, contractors, collaborators, and other relevant organizations as needed.
Prepares, performs, and documents personnel training to ensure personnel have the appropriate training and understanding of QA systems.
Performs timely review of batch production records; assures that batch records are complete, correct, and meet all pertinent documentation requirements.
Assists in review of all supporting documentation including but not limited to area and equipment log books, cleaning logs, and environmental monitoring data.
Assists in QA release of drug substances and drug products for distribution.
Verifies product release status for other departments; completes all appropriate release checklists and certifications.
Monitors and reviews validation projects.
Assists with management reports; area clearances; analyses of quality-indicating data trends; preparation of annual product reviews;
Quality Overall Summaries; investigation of deviations; corrective actions; variances; and product complaints; preparation and reconciliation of relevant portions of QA budget; preparation of SOPs, laboratory investigations, and training syllabi as needed.
Performs equipment calibrations, maintenance, and repairs.
Assists in qualifying new analytical procedures and instruments.
Performs other related duties as assigned by management.
QUALIFICATIONS:
Bachelor’s degree (B.S.) in chemistry, biology or equivalent.
Two to four years related experience or equivalent.
Strong knowledge of pharmaceutical manufacturing processes, computer and equipment validation
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Title: Quality Assurance Specialist
Company: Evestra, Inc.
Location: San Antonio, Texas, USA
Category: Quality Assurance – QA/QC, Healthcare
