Senior Quality Assurance Manager - Katalyst Healthcares & Life Sciences
Marietta, PA 17547
About the Job
Responsibilities:
- Perform root cause analysis which may require facilitation of cross functional teams to investigate deviations and determine robust corrective actions, lead problem solving sessions, and support recurrent and complex deviations using DMAIC.
- Support timely completion of TS quality system action plans. This includes writing, revising, or coordinating the efforts for change controls, SOPs, audits, and training documentation. Represent the TS department at the site change control meetings. Prepare and track change controls to make improvements outside of deviations.
- Include assessment of Global QMS (Quality Management System), Engineering, and EHS standards in creation and revision of TS SOP's to align with global requirements and requests.
- Track, trend, and evaluate TS misalignments and work to determine root causes. This includes tracking and trending progress of CAPA's (EHS and GMP) using a routine reporting system.
- Interact and coordinate with appropriate personnel including manufacturing, Supply Chain, TS, QA/QC, regulatory, etc. Communicate immediately with QA, Operations, Supply Chain, and EHS management for all TS discrepancies that impact product quality or safety.
- Develop internal GMP and EHS audit schedules (including area to be audited) on a yearly basis.
- Interact with external regulatory authorities as needed during routine and non-routine audits.
- Perform all job responsibilities in compliance with the safety procedures and all applicable EHS regulations, SOP's, and industry practices.
- Monitor process health through various governances, scorecards, data trending, etc. and problem solve or escalate issues when out of acceptable state.
- B.S or B.A in a technical discipline, preferably Microbiology, Biology/Virology, Biochemistry, Chemistry, Engineering or Pharmacy. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
- Minimum of 3 years pharmaceutical experience investigating manufacturing deviations either in a QA or manufacturing role.
- Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
- Demonstrated problem solving and investigational skills.
- Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance.
- The ability to communicate both verbally and in writing with all levels both inside and outside of the organization. The ability to clearly write technical documentation as necessitated by regulatory agencies and internal policy.
- Ability to establish and maintain working relationships with staff and the ability to analyze data and implement changes.
- Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA. Ability to work in a highly complex matrix environment.
- Able to prioritize and decide appropriate course of actions and to effectively implement decisions.
- Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.
- Able to maintain attention to detail while executing multiple tasks.
- Able to perform job duties with minimal supervision.
- Must be able to address complex problems associated with assessing deviations, determination of root cause, and implementation of change and improvement to validated and/or FDA approved production systems.
- Must have an aptitude for facilitating a team environment and working independently toward the goal of completing product investigations.
- Must operate cross-functionally and be able to lead in a matrix organization.
- Sense of urgency, flexibility and accountability.
- Intermediate computer skills required.
- Stay current on developments in the field and Standards.
- Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
- Maintain a high level of integrity while balancing multiple priorities and responsibilities.
Source : Katalyst Healthcares & Life Sciences