Principal Analytical QA Specialist, Drug Substance
New
L
LoyalVeterinary Pharmaceutical
Remote - USFull-TimeSenior
Salary$150,000 - $190,000
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Job Details
- Experience
- Minimum 12 years of relevant pharmaceutical industry experience, with at least 6 years in GxP QA roles.
- Required Skills
- Quality Assurance
Requirements
- B.S./M.S. degree in a scientific discipline such as Pharmaceutical Sciences, Chemistry, or Veterinary Science.
- Minimum 12 years of relevant pharmaceutical industry experience.
- At least 6 years of experience in GxP QA roles.
- Strong knowledge of FDA CVM regulations, cGMP, and VICH guidelines.
- In-depth working knowledge of drug substance development, analytical method validation, and stability programs.
- Experience managing CDMOs and collaborating in cross-functional team environments.
- Ability to work both in a team/matrix environment and independently.
- Demonstrated ability to handle multiple assignments and meet deadlines.
- Effective verbal and written communication skills.
- Ability to travel (10%).
Responsibilities
- Oversee all aspects of drug manufacture and testing through clinical development and into commercial phase.
- Provide Quality oversight for analytical method development, qualification, validation, transfer, release testing, and stability programs.
- Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies.
- Review and approve validation protocols, raw data, and reports for test method, process, and cleaning.
- Manage the batch release program by reviewing executed documentation, raw data, quality events, and product disposition decisions.
- Lead or support quality event resolution investigations, ensuring root cause analysis, CAPA development, and timely closure.
- Maintain effective communication with CDMOs and CTLs to ensure Quality objectives are achieved.
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