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Job #03549

About our client Our client is privately owned biotechnical company based in Maryland that is focused in developing platelets for use in clinical and research diagnostics. Position Location Sr. Quality Systems Associate Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Establish document approval and tracking processes as they relate to documentation for the development, manufacturing and quality control of all ASP products (pharmaceuticals and medical devices). 2) Lead effort to establish company as a cGMP compliant manufacturing facility. 3) Lead effort to establish company as a ISO compliant manufacturing facility. 4) Establish internal Risk Management system to investigate product failure, customer issues, complaint handling and corrective and preventive actions (CAPA). 5) Responsible for the execution of the validation processes. 6) Responsible for establishing and carrying out a calibration and routine maintenance program for all company equipment involved in product development, manufacturing and quality control activities. 7) Responsible for setting up and leading Product reviews; at least annually. 8) Leads CAPA Team for Complaint reviews and ensures that complaints are documented; evaluated; investigated in a timely manner; including corrective and preventative action(s). 9) Leads Discrepancy and failure investigations related to raw materials, manufacturing processes and quality testing. Ensures that discrepancy is documented, evaluated and investigated in a timely manner; including corrective and preventative action(s). 10) Change Control: documented, evaluated, approved and need for revalidation assessed. 11) Design Team Function. 12) Serves as Team Leader for the following: - Reprocess / Rework: Evaluation and review to determine impact on regulatory requirements, validation and stability and approve/reject the request. - Returns / Salvages product: assessment, investigation and disposition of the product. - Rejected material(s), component(s): Investigation and disposition of, and CAPA when applicable. - Stability Failures: investigation, need for field alerts/recall evaluated, disposition and CAPA. - Quarantine material(s) / Component(s) investigation and disposition. - Validation: status of required validation/revalidation (e.g., computer systems, manufacturing process, laboratory methods). - Ensure Training/qualification of employees with respect to GLP, cGMP and regulatory compliance as it relates to product development (design control), manufacturing and quality control functions. 13) Performs internal and external audits and initiates CAPA where required. 14) Coordinate Customer and Regulatory Agency audits of OFD facilities. Requirements 1) Bachelor’s degree in life science field required. Engineering degree an asset. 2) Min 4 years experience in the pharma industry or appropriate regulatory agency. 3) Knowledge of the cGMP policies, Code of Federal Regulations, cGMP guidelines, and regulations for pharma and medical devices required. 4) Experience conducting training sessions, making presentations and facilitating group discussion is preferred. 5) Demonstrated proficiency in windows-based software is required. 6) Experience in a quality function is desirable.