QA Specialist III - QCA
Working in Quality Assurance at Gilead:
Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies.
As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Meet the worldwide QA Team: https://qualityassurance-careers.gilead.com/
Key Responsibilities
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
- Reviews and approves controlled documents (e.g., SOPs, specifications, methods, change control, protocols, reports, investigations, deviations, CAPAs, etc.) to ensure defined quality objectives are met.
- Interfaces with operating entities and contract partners to address documentation and compliance issues.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Gilead Quality Assurance Lead for major quality investigations/deviations/clinical complaints, may represent QA on Materials Review Boards, quality event escalation meetings, and effectively communicates and escalates major and/or critical events to upper management in a timely manner.
- Reviews and approves method validation and/or transfer documents including protocols, reports, methods, change controls and specifications for small molecules and/or large biologics for analytical operations, and contract labs/manufacturers across the clinical and commercial supply chains.
- Possesses experience/knowledge in laboratory controls, method validation and method transfer guidelines per FDA/EU/ICH/USP/JP guidelines.
- Reviews and improves existing quality procedure workflows, identifies areas of improvement for efficiency and compliance.
- Serves as QA project lead, leads complex quality investigations/deviations, and independently reviews and approves concise quality investigation reports with appropriate corrective action and preventive actions (CAPA).
- Acts as an Analytical QA subject matter expert in support of regulatory inspections and internal audits.
- Active participant on projects, initiatives, and process improvements.
- As a quality functional site lead at CTLs support quality initiatives and responsible for providing quality metrics, trend reviews, and risk assessments.
- Reviews and audits method validation related data in CMC sections of NDA / global filings.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
- May assist with cGMP compliance audits at contract partners and may interface with regulatory agencies during inspections.
Knowledge, Experience and Skills:
- Strong background in laboratory investigations (OOS, OOT, Atypical), deviations and associated CAPAs.
- Strong background in analytical method validation and transfer.
- Proficient in application of FDA OOS Guidance, MHRA OOS Guidance and general QA principles, concepts, industry practices, and standards.
- Proficient in Root Cause Analysis Tools (e.g. Fishbone Diagrams and Failure Mode Effects Analysis, 5 Whys).
- Working knowledge of Risk Management Tools (e.g. root cause analysis, decision trees, risk registers).
- Possesses practical experience in a pharmaceutical GMP analytical testing laboratory focusing on method validation and investigations.
- Experience in a Pharma / Biotech GMP environment and a Bachelor's degree in chemistry, microbiology, or related scientific field.
- Expertise in Quality Systems and cGMP standards applicable to method validation for clinical and commercial products and AO/QC laboratory operations.
- Proficiency in phase appropriate validation of small molecules, biologics and solid oral dosage forms is required.
- An accountable team player who is detail and quality-oriented with solid understanding of quality assurance principles, systems, methods and procedures.
- Excellent attitude with good verbal, interpersonal communication, excellent judgment and multitasking skills who can adapt to changing priorities.
- Ability to work independently and effectively coach peers in a high-paced environment with tight timelines, while maintaining accuracy and quality.
- Demonstrates ability to effectively manage multiple projects/priorities.
- Possess critical thinking skills when making sound quality decisions based on risk management and available data.
- Ability to recognize deviations from accepted practice and apply knowledge of current Good Manufacturing Practices (cGMP) daily.
- Has proven analytical and conceptual skills.
- Advanced Microsoft office application skills are highly desired for creating and presenting reports.
- Ability to effectively generate metrics, and present; data, findings, and improvement initiatives/projects to QA and cross-functional leadership.
Basic Qualifications
- 6+ years of relevant experience and a BS or BA OR 4+ years of relevant experience and a MS
- Prior experience in the pharmaceutical industry is preferred.