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Technical Manager, QA

San Diego Metro Area, CA

Post Date: 04/30/2018 Job ID: JN -042018-21462 Job Type: Engineering
The Technical Manager, Quality Assurance reviews cGMP relevant documents. Focuses on implementation of the Quality Program and its continuous improvement to ensure compliance with phase appropriate cGMP. Assesses gaps during documentation reviews, KQI trending, Product Quality Reviews and proposes the need for improvements such as additional training on current applicable CGMP topics and industry standards. Organizes Management Review Meetings, training webinars, initiates procedures and policies required for the Implementation of Quality Program and continuous improvement. Assist during audits and inspections

ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Works with cross-functional teams to ensure all New Supplier Requests forms are submitted on time to QA for audit planning, creates audit agenda and coordinates audits with external suppliers.
  • Updates Audit Plan on a periodic basis, maintains Supplier Audit Logs, Approved Supplier List to ensure that it is current.
  • Follows up with suppliers on a periodic basis to ensure timely completion of paper audit and any Preliminary Supplier Evaluation.
  • Creates and periodically updates internal audit plan, performs internal audits for assurance of cGMP compliance and adherence of STI guidelines and SOPs within STI operations.
  • Communicates audit findings in a timely manner to the auditee, provides recommendations (as necessary). Writes internal audit reports and follows up on completion of any open CAPA deemed necessary that were communicated and documented to the auditee.
  • May assist with training on various cGMP topics e.g. Good Documentation Practices, USP<1224>, USP<1225>, USP<1226>, ICH Q1 and ICH Q2, Review of Analytical Documentation and Raw Data, SOP training, etc.
  • May assist in the keeping or preparation of meeting agenda, meeting minutes during Management Review Meetings and other important company meetings.
  • Ensures adequacy of procedures for phase appropriate cGMP compliance.
  • May assist in issuance of Lab Notebooks, Equipment Log Books and ensure a complete inventory is maintained in Document Control for all Notebooks and Log Books issued and received.
  • May assist in maintaining STI Signature Authority Log and Employee Signature Log.
  • Assists in establishing procedures for the generation, revision, and control of new and revised GXP documents.
  • May issue numbers for Quality Events, OOSs, Deviation Reports, NCMRs, CAPAs, etc.
  • Ensures CAPAs address the Root Cause(s) and Contributing Factor(s) and ensures a realistic timeline for implementation of CAPAs.
  • Follows up on open excursions to ensure timely completion of investigation reports.
  • Ensures that facility and equipment changes are tracked and any revalidation needs are assessed in accordance with applicable regulatory requirements, internal policies and procedures and phase appropriate cGMPs.
  • Performs Effectiveness Checks by following up on closed CAPAs, Change Controls and Trainings. Reports recurrence of quality issues and/or excursions to Sr. Director, Quality Assurance in a timely manner.
  • Assists with periodic review of all SOPs and other procedural documents to ensure that documents reflect current practices.
  • Works with other departments to review documentation for other possible improvements or efficiencies. Update procedures as necessary and ensure documentation exists showing the completion of periodic document reviews.
  • Interacts with all departments, works on ways to continuously improve current practices to meet quality plan, corporate goals and objectives.
  • Prioritizes projects appropriately and with flexibility to accommodate changing corporate objectives.

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