Quality Assurance Engineering Manager jobs in Nevada

Summary: The Quality Assurance & Quality Control Manager is responsible for ensuring compliance with internal SOPs and applicable regulatory guidelines and requirements. This role requires attention to detail organization, multi-tasking, and ability to interact with people who might be junior or senior to the incumbent Manager.

Specific Responsibilities:

• Monitor Quality System which includes proper document management protocol for all company Standards Operating Procedures.
• Directly supervises laboratory personnel while ensuring lab quality, accuracy of manufacturing processes, and continually improving staff capabilities through coaching and mentoring.
• Confirms that personnel have been appropriately trained and have demonstrated competency prior to working in the laboratories or with product.
• Ensure Regulatory Inspection Readiness:
  • Maintain inspection readiness through inspection preparedness program and periodic readiness verification through internal audits.
  • Execute against plan (training, document readiness, response preparation and readiness)
• Maintaining the Quality Systems in compliance with cGMP 21 CFR 820, 210/211 and CGTP and, State applicable regulations.
• Provide support to other functional areas for dealing with Deviations, CAPA, Change Control, Complaints and Recalls.
• Create and update SOPs, company Policies and other GMP documents. 
• Support and maintain the internal audit schedule.
• Manage Compliance Documentation and Licensing
• Establish a calendar to provide visibility to compliance documentation requirements.
• Generate and provide required documentation to clients and Regulatory authorities.
• Orient, train, monitor and evaluate employee’s performance. Ensures staff is properly trained on compliance standards.
• Responsible for disciplining direct reports for performance or personnel issues.
• Report the performance of the Quality System to the Executive Management Team including deviations from the Quality System and needs for improvement, on a periodic basis.
• Oversee implementation of corrective actions relating to vendor audits, monthly deviation, adverse reactions, and error reports.
• Ensures Quality System is consistent with current accreditation standards and advises where adjustments are warranted.
• Ensures all state and federal licenses are met and establish a calendar for renewal.
• Ensure the approve or reject all product(s) related to product, components, drug product containers, closures, in-process materials, packaging material, labeling, and has the authority to review production records, batch records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting the product(s).
• Strong understanding of cGMP’s and concepts in several quality systems.
• Demonstrated ability to work on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Strong oral and written communication skills.
• Ability to negotiate needed actions and manage difficult interactions effectively.
• Knowledge of computerized support tools and software for audit tracking and reporting.  Demonstrated knowledge of root cause/trend analysis/risk analysis. 
• Demonstrated knowledge of quality processes and compliance.
• Demonstrated ability to multi-task and work on several projects and problems.
• Ability to independently determine and develop approach to solutions.
• Unquestioned integrity and ethics with a confident but well-grounded approach to doing work.

Education/Experience:

• BA/BS in Biology, Chemistry, or similar Science education.
• 5 years QA or related experience working in a regulatory environment or position (GLP, GCP or GMP) with a minimum of 3 years of experience within Biopharmaceutical industry.
• Prior auditing experience preferred.

Working Conditions

• Busy working environment with combination of laboratory and office settings.
• Frequently required to walk, stand, stoop, keel, reach and sit.
• Requires full range of body motion including manual and finger dexterity and eye-hand coordination.
• Frequent standing and working for extended periods of time.
• Must be able to lift and carry items weighing up to 50 to 100 pounds.