The Sr. Quality Assurance Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards. The role reviews and approves investigations including but not limited to non-conformance, CAPA, deviations, OOS, complaints, and creates reports that comply with regulatory requirements including root cause analysis and impact assessments. Additionally, the role is responsible for final review of product from manufacturers.
Essential Duties & Responsibilities: • Review and approve CAPA, deviation, OOS, and nonconformance records provided by contract manufacturers. • Manage/support internal CAPA, deviation, OOS, and quality investigations. • Review and approve external customer complaints and adverse events, and mitigate issues related to them. • Ensure investigations of quality events are timely and maintained through interdepartmental communication. • Review and identify trends in the quality systems data. • Review and approve incoming product, COA, and batch records to release product to market. • Advise contract manufacturers of proper documentation and specifications requirements needed for new and ongoing products. • Serve as a Quality representative on cross functional team meetings as required. • Troubleshoot and initiate the resolution of Quality issues by fostering interdepartmental and cross-functional partnerships. • Effectively manage multiple tasks and work under pressure.
Required Skills / Experience / Competencies: • Bachelor's degree in science or related field (Biology, Chemistry, Physics, Engineering). • Minimum 5 years' relevant Quality/Regulatory experience (FDA preferred). • Proficient understanding of cGMP requirements within the OTC/FDA regulated space. • Excellent written and verbal communication skills. • Proficient in Microsoft Word, Excel, PowerPoint. • Strong teamwork skills. • Strong critical thinking and decision-making skills.
Preferred Skills / Experience / Competencies: • Experience in consumer goods, preferably personal care, and OTC's. • Knowledge pertaining to the regulations related to FDA CFR 21 Part 210/211, Health Canada, TGA, and EU. • Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs). • Experience working with software systems such as Coptis, Airtable and ASANA preferred.
Compensation: • $72,320-94,920 is the salary range for this position. It represents a portion of the overall package, and includes flexibility based on the candidate's qualifications.
Job Requirements: • Full Time • Up to 5% travel
Other duties, responsibilities and activities may change or be assigned
at any time with or without notice as assigned by the Manager. The job description
does not constitute a contract of employment and the position remains at-will.