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Quality Control Analyst- Pharma Gmp
Company | Integrated Resources, Inc ( IRI ) |
Address | United States |
Employment type | CONTRACTOR |
Salary | |
Category | Medical Equipment Manufacturing,Biotechnology Research,Pharmaceutical Manufacturing |
Expires | 2023-09-05 |
Posted at | 10 months ago |
The Service QC Analyst position within the Global Service team provides a critical contribution to the overall quality and regulatory compliance of globally distributed field service teams. More specifically they will review, evaluate, and record activities and findings as part of an ongoing global field service quality control process. This position will follow established procedures to complete reviews and maintain records to identify levels of compliance aProductst expected targets and standards of service documents. Direct communication and collaboration with distributed service teams will be fundamental to the success of this role. Ability to follow up effectively will be necessary. Data analysis and problem-solving skills are necessary to identify and countermeasure common failure issues. Robust documentation and strict adherence to approved procedures are a requirement in the highly regulated work environment. Typical related responsibilities will include but are not limited to the following: Work with a variety of people and roles within the company such as Customer Technical Specialists, Field Service & Application Engineers, and service leadership personnel to facilitate an organization which meets/exceeds all service documentation compliance targets. Evaluate documentation of service records aProductst expected standard across a complex product portfolio. Product and utilize basic product technical awareness to facilitate informed evaluation of technical steps taken as evidenced within the service records being reviewed. Understand and utilize service workflows and procedures to determine accountable groups and individuals when gaps are found. Initiate remediation of service records and/or generate customer complaints when gaps are revealed. Utilize MS Excel analytics to provide service leadership with reporting as well as trending of failures including recommendations for improvement. Communicate with Customer Technical Specialists, Field Service & Application Engineers to gather more data when needed. Provide input into associated procedural edits to enable further improvements and streamlining as appropriate. Complete all needed records in a timely and accurate manner within the service management and documentation systems. Provide specific question response and additional support as required for internal and external audit. Participate in problem solving teams as needed. Contribute to CAPA teams when needed to ensure timeliness of needed improvements. Perform weekly / monthly monitoring reporting as determined with clear indications of performance level to target. Develop and deliver MS Power Point presentations to key stakeholders and/or the local service teams on levels of compliance as well as areas of success and known performance gaps. Complete all needed records in a timely and accurate manner. Knowledge/Educational Requirements: Bachelors degree in field with 0-2 years exp. Quality or Service. related IT, Audit, Field Engineer, Biomed. Uses existing procedures to solve standard problems; analyses information and standard practices to make judgments.
Additional Job Details:100% Remote Position (anywhere in the US) Bachelors degree required (no specific subject) Problem solving experience Experience with GDP / experience in a regulated environment preferred Service experience preferred
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