About Discovery Life Sciences:
Discovery Life Sciences (Discovery) is a leading provider of highly characterized human biospecimens and cellular starting materials to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions. We routinely manage hundreds of studies and expertly test thousands of biospecimens simultaneously. Leading biopharma, diagnostic and academic institutions trust us to quickly deliver high-quality biospecimens and reliable, reproducible biomarker data, so they can outpace their competition and push the leading edge of innovation using our Science at your Service TM business model.
Position Summary:
Discovery is looking for a talented and 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.
A Day in the Life of a Senior Quality Assurance Specialist at Discovery Life Sciences:
- Provide oversight of CAPAs and doc control for assigned group(s)
- Perform internal audits and provide support for external audits
- Review and respond to department inquiries
- Communicate quality needs and feasibility for product releases
- Provide oversight of equipment maintenance and calibration schedules
Position Qualifications (Education, Skills, Experience):
- Bachelor’s Degree in life sciences preferred
- 5+ years’ of quality assurance experience
- Life sciences/pharmaceuticals/diagnostics industry experience required
- Strong understanding of GxP/ISO regulations and quality management systems.
- Experience conducting/hosting quality audits, inspections, and assessments
- 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.
- Working experience with eQMS, ERP systems and other information systems.
Key Responsibilities:
- Review 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.
Compensation and Benefits:
Discovery Life Sciences is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated total compensation range is $85,000-$105,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.Your annual salary is only one part of your total compensation package. Other benefits:
- Competitive salary and benefits package options including free medical, dental, vision, life, and disability which start on your first day of employment. Free medical, dental and vision options for you and your Family members!
- 401(k) match program which starts on your first day of employment
- 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
Location and work hours:
- Onsite – Alameda, CA location.
- Flexible work schedule, start time between 7am and 9am local time.
- Travel – Less than 5% domestic and international travel.
We are actively seeking motivated, dedicated individuals like you to join our thriving organization. As a leader in our industry, we offer unparalleled opportunities for professional growth and success. Apply Now to join our team! Visit dls.com/careers for more details.
