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- St Petersburg Florida, FL
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Manager, Quality Assurance
Apex Systems • St Petersburg Florida, FL
Posted 11 days ago
Apex Systems is seeking candidates for a Quality Assurance Manager with a Pharmaceutical background for an opening in St. Petersburg, FL!
The Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support within the job site. The Department has the responsibility for Quality aspects including but not limited to Quality Systems, Finished Product Batch Release, Training, Internal/External Audits, Complaints, APR, Investigations, Document Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of the Quality Unit and could include all or some aspects of the Quality function.
II. Basic Function:
The QA Manager 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 Corporate Quality Policies and applicable quality standards across the area of focus. Position requires partnership with other functional areas (e.g. Product Development, Operations, Customer Service, Validation, Quality Control, etc.) to ensure continued compliance for the area/site. Will provide directional support and as required, hands on, leadership to drive actions and enhancements to the QMS.
III. Specific Activities, and Responsibilities:
Ensure Quality systems are compliant with corporate and site procedures, regulatory requirements and industry standards for systems such Deviation investigations, Batch record review, Equipment/Facilities, root cause analysis, Corrective and Preventive Actions, Drive continuous improvement initiatives in previously listed QMS. Oversees Deviation investigation system to ensure timely closure of deviations, corrective actions, effectiveness checks, etc. 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. Manages 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. Function as the Quality department liaison and subject matter expert to other department representatives, customers and regulatory representatives. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the manufacturing processes and corporate goals. Participate in Regulatory Inspections. Author and maintain detailed Standard Operating Procedures defining Quality Systems. Author/compile monthly, quarterly and annual summaries and metrics. Present summary data to site management on a regularly scheduled basis. Quality liaison for clients and internal customers. Direct reports manage daily client interactions. Is expected to become the escalation point for client requests/issues. Accountable for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus. Effective 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 Quality Assurance input with respect to compliance to cGMP requirements. Reviews and approves technical documents, such as, but not limited to: 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. Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines). 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. Ability to investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities. Responsible for performance management of employees. Fosters and facilitates a culture of retention for the site. Provides directional steer to employees to achieve goals. Guides, instructs, and coaches members of management in compliance issues. Develops short and long-range goals and objectives for the site quality function. Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
IV. Knowledge Requirements:
Bachelor’s Degree in Science (Chemistry, Microbiology or Biology preferred). A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries. Experience working with customers. 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. Intermediate to proficient skills in Microsoft Office applications. Knowledge/Skills Requirements: Prior quality assurance experience is required. Working knowledge of cGMPs and/or OSHA regulations required. Prefer experience in multiple regions (e.g EU, ANVISA, FDA, Etc.)
Certified Quality Engineer is a plus.
Excellent oral and written communication skills a must. Proficient in Microsoft Word, Excel, Access and Power Point. Attention to detail when utilizing PC or reviewing documents and editing/proof-reading documents. Ability to speak effectively and present before groups within the organization. Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways. Ability to review and evaluate technical documents and determine impact to processes and systems in place. Ability to solve problems with minimal guidance. Ability to review and write protocols, reports, and procedure manuals. Ability to effectively present information and respond to questions from peers, management, suppliers and customers. Motivated, self-started, team player.
Physical/Mental Requirements: Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds. Be accessible to manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
Work Environment: Individual’s primary workstation is located in the office area, where the noise level is low.
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178