Quality Assurance Operations Sr Specialist

The Quality Assurance Operations Sr Specialist is responsible for a variety of operational activities pertaining to assuring product quality and compliance to the manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product for commercial and clinical distribution.

Responsibilities

• Support various Chemistry, Manufacturing, and Controls (CMC) projects
• Participates in Quality oversight of Contract Manufacturing Offsite (CMOs)
• Reviews and approves Quality investigations, including deviations, Out of Trends/Specification, and Lab Investigations as designated by higher level
• Review and approves CAPA and Change Controls
• Reviews and approves specifications for labels, finished products, and raw materials
• Perform review of executed batch records and test data, and perform product dispositions
• Review and approve master batch records
• Manage product complaint processes
• Support internal audits and may support quality audit of suppliers, CLOs, and CMOs
• Perform quality trends analysis and reports, recommending continual improvements opportunities

Preferred Education & Experience

• BS/BA degree in a scientific discipline
• 6+ years in bio/pharmaceutical Quality Assurance
• Knowledge in application of 21CFR211, global cGMP regulations, and ICH guidelines regarding good manufacturing practices in the development, manufacturing, testing, delivery, and control of pharmaceutical products

 Skills, Qualifications or Technical Proficiencies

• Technical knowledge of analytical chemistry and pharmaceutical manufacturing technologies and processes
• Experience with executed batch record review and in-depth knowledge of quality and regulatory requirements for the release of pharmaceutical products
• Ability to work independently and communicate effectively with project team members and cross-functional stakeholders and suppliers
• Work well in a project team environment with solid problem analysis and decision-making ability.
• Ability to work independently
• Clearly and concise written and verbal communication
• Ability to identify compliance risk and recommend mitigations
• Ability to contribute to the development of author, review, and approve SOPs and other controlled documentation for compliance with applicable regulations
• Strong statistical mindset and metric presentation
• Proficient computer skills are needed with experience using Microsoft Word, Excel, PowerPoint, and Visio
• This job requires 10% travel

The pay range that the Company reasonably expects to pay for this position is $115,000 - $138,400; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education.  An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and other wellness benefits, dependent on the position offered. 

Applicants must be currently authorized to work in the United States on a full-time basis.

If you are based in California, we encourage you to read this important information for California residents linked here.