Sun Bum
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.
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:
Bachelors 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 OTCs. 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:
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. Seniority level
Associate Employment type
Full-time Job function
Quality Assurance Industries
Personal Care Product Manufacturing #J-18808-Ljbffr
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:
Bachelors 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 OTCs. 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:
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. Seniority level
Associate Employment type
Full-time Job function
Quality Assurance Industries
Personal Care Product Manufacturing #J-18808-Ljbffr