Quality and Compliance Specialist

The Quality & Compliance Specialist (QA) position at Piramal Pharma Solutions HPAPI Research and Manufacturing facility in Riverview, Michigan requires a dedicated individual to join the Quality Assurance (QA) team. The primary focus of this role is to support the manufacturing operations of the 24x7 facility while ensuring compliance with regulatory standards set forth by the United States Food and Drug Administration (USFDA) and other international authorities. The successful candidate will be responsible for implementing, executing, and maintaining Quality Systems related to manufacturing processes at the PPS-Riverview site. Key responsibilities of the Quality & Compliance Specialist include reviewing batch production records to ensure compliance with Good Manufacturing Process (GMP) requirements, supporting operations by promoting adherence to Good Manufacturing Practices, and carrying out administrative duties such as issuing master production records and maintaining document tracking systems. The Specialist will also be involved in conducting audits, preparing reports, and participating in Quality Systems Metric Reporting and analysis. To qualify for this position, candidates must possess a Bachelor's degree in physical or biological sciences/engineering with at least 1 year of experience in pharmaceutical operations/quality or a related field. Alternatively, an Associates degree with 2 or more years of relevant experience will be considered. Strong knowledge of GMP requirements, proficiency in MS Office, and experience with document management systems are essential for this role. Additionally, excellent organizational, communication, and analytical skills are required to succeed in this position. The successful candidate must be willing to work on a shift-based schedule, including weekends and holidays as needed. The induction period for this role is 3 months, with an expected time to reach performance effectiveness within 6 months. As part of the job conditions, individuals in this role may be exposed to hazardous chemicals and will be required to wear appropriate personal protective equipment. If you are a detail-oriented individual with a strong background in quality assurance and compliance, this role offers an opportunity to contribute to the success of the pharmaceutical manufacturing operations at Piramal Pharma Solutions in Riverview, Michigan.,