Manager, Quality Assurance

St. Petersburg, FL

Posted: 03/15/2019 Job Number: JN -032019-10541
QA Manager (Pharmaceutical):

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: QA Manager Pharmaceutical
  • Location: St. Petersburg, FL (Feather Sound Area)
  • Industry: Pharmaceutical
  • Hours: Monday-Friday; 8:00 am 5:00 pm
  • Salary: $45.00-$50.00 hour paid weekly with benefits options
  • Employment Type: Contract To Hire
Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products. Isn t this the type of company you want to work for?

Job Scope: This position is responsible for managing aspects of Quality Assurance representing a staff of approximately five to ten associates which includes QA Product Managers responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: change controls, material/product specifications, test methods, product process validation and cleaning validation documents.
  • Responsible for ensuring the site is in compliance with cGMP guidelines, adherence to Quality Policies and Standards. Partners with other functional areas to ensure compliance for the site
  • Provide directional support and leadership to drive actions and enhancements to the QMS
  • Ensure Quality systems are compliant with corporate procedures, regulatory requirements and industry standards for systems such Deviation investigations, Batch record review, Equipment/Facilities, root cause analysis, CAPAs, Drive continuous improvement initiatives
  • Oversee Deviation investigation system to ensure timely closure of deviations, corrective actions, effectiveness checks. Ensures investigation teams conduct thorough root cause analysis, identifies and implements corrective and preventive action plans to eliminate repeat observations and reviews/approves deviation investigations
  • Manage team routinely engaging in client interactions and client audits and participates in those activities as needed
  • Manages team responsible for performing batch record review and disposition activities for commercial and clinical trial batches
  • Work on complex issues where analysis requires an in-depth knowledge of the manufacturing processes and corporate goals
  • Participate in Regulatory Inspections
  • Author and maintain detailed SOPs defining site Quality Systems
  • Author/compile monthly, quarterly and annual summaries and metrics
  • Present summary data to site management on a regularly scheduled basis
  • Liaison for clients and internal customers
  • Direct reports manage daily client interactions
  • Escalation point for client requests/issues
  • Accountable for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus
  • Coordination of functions across the site and with clients to drive timely review, approval, and closure of investigations, corrections, and effectiveness checks
  • Review quality metrics, trackers, and reports to characterize the health of the client relationship and state of quality systems.
  • Provide QA Technical recommendations based on trend analysis to eliminate future problems
  • Participates in R&D/Technical Services/Validation/Engineering project meetings to provide QA input with respect to compliance to cGMP requirements
  • Reviews and approves technical documents, such as Technical Services Protocols and Reports; Process Validation Protocols and Reports; Cleaning Validation Protocols and Reports; Protocols and Reports; Material and Product specifications; Test methods; Master Batch Records; and Master Shipper Labels. Change Control, as it pertains to the above validated/qualified systems and controlled documents
  • Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers and routine production
  • Provide support to internal, client, and regulatory audits
  • Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at all times
  • Investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities
Skills Needed:
  • Bachelor s Degree in Science (Chemistry, Microbiology or Biology preferred)
  • 5-10 years related experience in the QA pharmaceutical industries
  • Prior quality assurance experience is required
  • Working knowledge of cGMPs and/or OSHA regulations required
  • Experience working with customers
  • Ability to speak effectively and present before groups within the organization
  • Prefer experience in multiple regions (e.g EU, ANVISA, FDA, Etc.)
  • Certified Quality Engineer is a plus
  • Contract manufacturing experience preferred
  • Prior experience working with validation or technical services preferred
  • Proven ability to multi-task and demonstrate diplomatic skills
  • Must possess excellent English verbal and written communication skills
  • Proficient in Microsoft Word, Excel, Access and PowerPoint
EOE/ADA

QA Manager , Manger QA , Quality Assurance, cGMP, GMP, Pharmaceutical
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