Manufacturing Quality Assurance Specialist

The Manufacturing QA Specialist in the Pharma Solutions division at Lexington plays a crucial role in ensuring compliance with regulations and standard operating procedures. You will be responsible for overseeing quality activities throughout the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products. Reporting to the QA Supervisor, you will review batch records, protocols, and documentation, collaborate with departments to address issues, and conduct on-the-floor activities like line clearances and product inspections. Your role will also involve providing QA oversight, troubleshooting GMP issues, and offering leadership on projects that interact with other departments. Additionally, you will support meetings, audits, investigations, and technical reports, execute training plans, and ensure adherence to regulatory guidelines. To qualify for this position, you should have a high school education or equivalent, with a Bachelor's Degree in physical or biological sciences being preferred. Previous experience in quality-related activities within a manufacturing environment, particularly pharmaceutical manufacturing, is required. Familiarity with cGMP and FDA regulations, as well as proficiency in Microsoft Office applications, is essential. Strong communication skills, attention to detail, and the ability to follow instructions are necessary. Knowledge of sterile manufacturing and technical writing skills are advantageous. Piramal Group, with its commitment to inclusive growth and ethical practices, values merit-based employment decisions. Equal employment opportunities are provided to all applicants and employees, ensuring fairness in recruitment, training, promotion, compensation, and working conditions. The Piramal Pharma Solutions team operates as a Contract Development and Manufacturing Organization (CDMO), offering comprehensive solutions across the drug life cycle. Through global facilities in North America, Europe, and Asia, the team provides services such as drug discovery, pharmaceutical development, clinical trial supplies, and commercial APIs and finished dosage forms. Specialized services include the development of highly potent APIs, sterile fill/finish, peptide products, and biologics like vaccines and monoclonal antibodies. If you are looking for a challenging role that combines quality assurance in pharmaceutical manufacturing with regulatory compliance and leadership opportunities, this position as a Manufacturing QA Specialist could be the right fit for you.,