Melissa Owens| President
P : (386)339-0839 |E : melissa@alliedsearchpartners.com
Schedule a Meeting : Job Description
Job Title : Senior Quality Assurance - Permanent
Location : Alameda, CA
Shift : Flexible work schedule, start time between 7am and 9am local time / Hybrid - at least 4 days per week.
Job Summary : A passionate Senior Quality Assurance Specialist to play a vital role in ensuring the quality and compliance of our products business. The person in this position will collaborate with various departments, including manufacturing, R&D, and regulatory affairs, to review documentation, conduct / host audits, investigate deviations, lead projects, and help manage document lifecycles. Additionally, the Senior Quality Assurance Specialist will perform back-up quality control duties.
Benefits :
- Free medical, dental and vision options for you!
- 401(k) match program
- Flexible work hours
- Time away from work (Generous vacation and paid time off, your BIRTHDAY, paid parental leave, paid family leave, etc.)
- Professional development opportunities and reimbursement for relevant certifications.
- Collaborative and inclusive work environment that values diversity
- Team-building activities and social events
- Employee Referral Program and Colleague Recognition Program
Job Responsibilities Include :
Provide oversight of CAPAs and doc control for assigned group(s)Perform internal audits and provide support for external auditsReview and respond to department inquiriesCommunicate quality needs and feasibility for product releasesProvide oversight of equipment maintenance and calibration schedulesReview and approve batch records, laboratory data, standard operating procedures (SOPs), specifications and other quality documentation for completeness, accuracy, and compliance with regulatory standards (e.g. FDA, GxP).Conduct audits and inspections to assess compliance with applicable regulations (e.g. FDA, GxP) and company procedures.Investigate deviations from established procedures and protocols and implement corrective and preventative actions (CAPA) to prevent recurrence / occurrence.Participate in the development, implementation, and maintenance of quality systems and procedures.Provide training and guidance to colleagues on quality procedures and best practices.Contribute to the development and maintenance of quality management systems (e.g., QMS).Participate in risk assessments and develop risk mitigation strategies.Manage and track corrective and preventive actions (CAPA) to ensure timely resolution of quality issues.Stay up to date on current GxP regulations and industry best practices.Participate in the development and implementation of quality improvement initiatives.Maintain a comprehensive understanding of relevant regulations and quality standards (e.g., FDA, USP, ICH).Review training record compliance and report and investigate any discrepancies or shortcomings.Provide guidance and training to manufacturing and lab personnel on quality procedures, documentation practices, and regulatory requirements.Participate in data analysis and reporting activities.Conduct internal audits and support external audits and Inspections.Perform internal and external quality assessments, including vendor audits and inspections, to ensure adherence to quality standards and contractual agreements.Maintain accurate and complete quality documentation, ensuring proper recordkeeping.Requirements :
Knowledge of quality tools / concepts and their application such as Document Control / Change Control, Deviations, Corrective / Preventive Action, Internal Audit, batch record review, statistical process control, etc.Strong understanding of GMP / ISO regulations and quality management systems required.Experience - 7 years' of quality assurance experience. Experience conducting / hosting quality audits, inspections, and assessments. Life sciences / pharmaceuticals / diagnostics industry experience required. Working experience with eQMS, ERP systems and other information systems.
Education - Bachelor's Degree in life sciences preferred.
