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Sr. QA Specialist

Sr. QA Specialist

Cellipont BioservicesThe Woodlands, TX, USA
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Job Summary

Cellipont Bioservices is growing, and we are looking for a Sr. QA Specialist, Operations who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.

The Sr QA Specialist, Operations will play a critical role in ensuring the quality and compliance of cell therapy manufacturing processes within a Contract Development and Manufacturing Organization (CDMO). This position involves supporting quality assurance activities, monitoring production processes, and ensuring compliance with regulatory standards. With knowledge of relevant regulations and technical expertise in cell therapy manufacturing, they contribute to maintaining high standards of quality and compliance within the organization. This role offers an opportunity to contribute to cutting-edge cell therapy projects and ensure the highest quality standards are met in the manufacturing process.

The Role

  • Assists in managing the Quality programs and systems to ensure compliance with Quality requirements and provides advice on GMP-related issues
  • Provides technical / compliance contributions to the resolution of Customer Complaints and supports in customer / regulatory audits
  • Assists with investigations, writes technical reports and regulatory documents
  • Reports Quality metrics weekly and monthly
  • Perform detailed reviews of batch records and related documentation to ensure accuracy and compliance with cGMP standards.
  • Provide QA oversight during manufacturing operations, ensuring adherence to SOPs and regulatory requirements.
  • Monitor production processes and conduct in-process inspections as part of the QA On-the-Floor program
  • Perform Area Clearances from lot to lot and ensure product changeovers are controlled and documented.
  • Assist in the investigation of deviations, participate in root cause analysis, and help implement corrective and preventive actions (CAPAs).
  • Assist in maintaining document control systems, including the revision and review of SOPs, protocols, and other quality documents.
  • Participate in internal audits to assess compliance with regulatory standards and identify areas for improvement.
  • Support training initiatives by guiding quality procedures and best practices to manufacturing personnel.
  • Stay current with changes to current Good Manufacturing Practices, including FDA, EU, and other regulatory bodies (relevant to Cellipont Bioservices activities) and guidance bodies including ICH, ISPE, etc.

The Candidate

  • Minimum of a B.S. in a Life Sciences discipline
  • 4 - 6+ years of experience in quality assurance within the biopharmaceutical industry, preferably in cell therapy or a CDMO environment
  • Strong knowledge of quality systems
  • Excellent attention to detail and problem-solving skills.
  • Effective communication and interpersonal skills.
  • Ability to work independently and as part of a team in a fast-paced environment
  • Knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
  • Technical and quality background related to biological manufacturing (preferably Cell Therapy)
  • Provides technical solutions to complex problems which require the regular use of ingenuity and creativity
  • Ability to quickly learn new and novel manufacturing processes supporting new clients
  • Able to work in a team setting and independently under minimum supervision
  • Familiarity with electronic systems, including developing and producing reports using Smartsheet and Excel
  • Requires the ability to produce quality results in a fast-paced environment to meet client deadlines

    • Position Benefits

  • Opportunities for career growth within an expanding team
  • Defined career path and annual performance review & feedback process
  • Cross-functional exposure to other areas of within the organization
  • Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members
  • 401K strong employer match
  • Tuition Reimbursement
  • Employee Referral Bonuses
  • Flexible work schedules and PTO based on role / level, increasing 1 PTO day each year and paid holidays
  • Gain experience in the cutting-edge cell therapy space

    • "At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!"

    Notice to Agency and Search Firm Representatives

    Cellipont Bioservices is not accepting unsolicited resumes from agencies and / or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and / or search firm without a valid written & signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.

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    Sr Qa Specialist • The Woodlands, TX, USA