Quality Assurance Specialist

BACKGROUND

Sentynl Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd. (Zydus), is a commercial stage biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases. With an emphasis on commercialization, Sentynl looks to acquire, develop and commercialize well-differentiated products across a broad spectrum of therapeutic areas to address a variety of genetic orphan and neurological disorders.  To support its latest acquisitions, Sentynl is searching for a Quality Assurance (QA) Specialist.

SUMMARY

The QA Specialist is responsible for performing day-to-day quality operations related to Sentynl’s pharmaceutical products. The QA Specialist will focus on performing tasks such as maintaining internal quality management systems, batch record review, review of release and stability testing results, assisting with training program maintenance, and working with and managing contract development and manufacturing organizations (CDMOs) to ensure compliance with current Good Manufacturing Practices (cGMP). The QA specialist will also support analytical method transfer activities for several ongoing tech transfers and review key method and process transfer documentation. The QA Specialist will report to the Sr. Director, Quality.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Perform day-to-day quality operations related to manufacturing and testing of Sentynl’s pharmaceutical products.
  • Assist with quality oversight of Sentynl’s CDMOs for manufacture and testing of Sentynl’s drug substances and drug products.
  • Monitor contract laboratory activities for both performance and quality of data.
  • Document Control activities – organize, manage, and control CGMP document lifecycles.
  • Assist with implementation, maintenance, and improvement of quality management systems including but not limited to SOP writing, deviations, change controls, investigations, CAPAs, and personnel training.
  • Assist with managing Sentynl’s supplier qualification program, including audit scheduling, following up on findings and CAPAs, assisting with the implementation and renewal of Quality Agreements.
  • Review change control requests to ensure the proposed changes are justified, supported by data, and have been appropriately validated when applicable.
  • Review investigations, deviations, CAPAs, product complaints, SOPs, and technical reports, as needed.
  • Assist in organizing and completing investigations, coordinate with CDMO or vendor involved, and drive closure in a timely manner.
  • Review master batch records, executed batch records, QC release and stability testing data and reports.
  • Manage product release and disposition according to internal procedures, current regulatory requirements, and CGMP compliance.
  • Review and approve method transfer/validation protocols and reports, analytical data sets and technology transfer protocols. Lead the validation and implementation of appropriate analytical methods in support of drug substance and drug product development across late-stage and commercial assets.
  • Manage Sentynl’s product serialization program.

KNOWLEDGE/SKILLS/ABILITIES

  • Strong knowledge of Quality systems, applicable CGMP regulations and having the ability to make independent decisions based on regulations and requirements.
  • Ability to identify quality and compliance issues, communicate issues to others, and identify resolutions efficiently and effectively.
  • Excellent communication, critical thinking, and organizational skills.
  • Strong ability in problem solving and prioritizing multiple tasks.
  • Good understanding of quality principles, regulations, industry practices, and standards with demonstrated ability to apply these to operations at CDMOs and Suppliers.
  • Adeptness at building collaborative relationships with internal and external stakeholders.
  • Independent decision making and willingness to seek guidance when unsure.
  • High degree of initiative.
  • Ability to work well independently and as a team member.
  • The ability to support or conduct supplier qualification audits is preferred but not required.
  • Understanding of analytical development strategies and method transfer.

EDUCATION/EXPERIENCE

  • Bachelor’s degree in a Life Science discipline or related field.
  • Minimum of 5 years of QA experience in a CGMP pharmaceutical, biotech or medical device environment or equivalent. Additional experience in QC environments is preferred.
  • Strong working knowledge of CGMP regulations.
  • Excellent communication (verbal and written), organizational, interpersonal, and computer skills.
  • Highly skilled at Microsoft Office (MS Word, PowerPoint, Excel, Outlook).
  • Ability to identify compliance issues, communicate issues to others, and identify resolutions effectively.
  • Fundamental understanding of tech transfer (e.g., test methods and manufacturing processes), stability program requirements, material disposition, OOS and deviation investigations.
  • Demonstrate strong ability to problem solve and prioritize multiple tasks.
  • Good understanding of quality principles, regulations, industry practices, and standards with demonstrated ability to apply these to operations at CDMOs and Suppliers.
  • Independent decision making with a high degree of initiative.
  • Ability to work independently and as a team member.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an individual would experience while performing the essential functions of this job.

  • Work location: Solana Beach, CA.
  • Normal office conditions.
  • Ability to travel up to 10%.

CORE VALUES & COMPETENCIES

Growth

  • Manages Ambiguity
  • Strategic Mindset
  • Demonstrates Self-awareness and Initiative
  • Cultivates Innovation

Accountability

  • Results Oriented
  • Ensures Accountability
  • Decision Quality

Transparency

  • Courage
  • Collaboration
  • Instills Trust

Ethics

  • Compliant
  • Unwavering commitment to doing what is right
  • Seeks guidance when unsure

COMPENSATION AND BENEFITS

Sentynl Therapeutics, Inc. offers a competitive salary program and an attractive benefits package that includes:

  • The base salary for the Quality Assurance (QA) Specialist will be $80k to $120k.
  • Medical/Dental/Vision Insurance
  • Company paid Life Insurance, Short-term Disability and Long-term Disability
  • 401(k) plan with a generous employer match
  • Unlimited PTO – based upon our trust of employees to manage their work schedule and mutual agreement between the employee and their manager.
  • Paid Holidays

Apply Now

Apply Now