QA Support (Pharmaceutical domain)

Role: QA Support

Location: California (Remote)

Position Overview

The QA Specialist III will support Quality Operations in a dynamic pharmaceutical environment, bringing a broad skill set with a strong focus on QA activities. This role requires a deep understanding of GxP environments, document management, and quality risk assessment. The ideal candidate thrives in a fast-paced setting and is adept at handling diverse responsibilities.

Key Responsibilities

• Quality Metrics & Risk Management

• Support the reporting of quality metrics monthly and quarterly for management reviews and KPIs.
• Assist in implementing and maintaining quality risk management frameworks.

• Batch Record Review & Product Disposition

• Conduct batch record reviews and product dispositions for clinical trials, registration, validation, and commercial distribution.
• Assess completed manufacturing records (batch records, COA, COC, and related data) from CMOs for accuracy and completeness.
• Maintain real-time Continued Process Verification data collection during batch release.

• Quality System & Compliance

• Review and manage quality system documentation, including deviations, OOS reports, product complaints, CAPAs, and document/change control processes.
• Evaluate compliance requirements for document changes (SOPs, Master Batch Records, etc.).
• Analyze and report on product and process quality trends and quality system performance against regulatory and internal standards.

• CMO & Regulatory Oversight

• Support QA oversight of CMOs to ensure adherence to quality standards.
• Collaborate with Regulatory Affairs on manufacturing process changes affecting regulatory filings.
• Work with CMC to enhance compliance with quality systems, SOPs, and regulatory requirements while resolving deviations.

• Additional Responsibilities

• Assist in product complaint handling.
• Support the preparation of Annual Product Quality Reports.
• Participate in cGMP compliance audits of GMP suppliers.
• Conduct training sessions as needed.
• Perform additional duties based on company needs.

Qualifications & Experience

• Education & Experience

• Bachelor s degree in a scientific discipline or equivalent relevant experience.
• 7+ years of GxP experience in drug substance and drug product manufacturing, process development, commercial manufacturing, analytical development, and/or quality control.

• Technical Skills & Knowledge

• Hands-on experience in a manufacturing setting as a Quality representative.
• Strong understanding of quality risk management principles.
• In-depth knowledge of GMP regulations and guidelines (US, EU, ICH).
• Extensive experience with Quality Assurance systems and processes.
• Technical writing expertise with the ability to draft and review quality documentation.
• Proficiency in software tools including SharePoint, Visio, Project, Acrobat Pro, and Veeva (preferred).

• Soft Skills & Abilities

• Excellent organizational, planning, and problem-solving skills.
• Ability to handle frequent changes, unexpected challenges, and tight deadlines.
• Strong leadership, negotiation, and strategic planning capabilities.
• Effective communication and interpersonal skills, including experience interacting with executive leadership.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.