Sr. QA Specialist - QCA
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POST DATE 9/9/2016
END DATE 10/19/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing 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 Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
* Leads quality review of validation activities for analytical operations, and contract labs across the clinical and commercial supply chains.
* Reviews and approves validation related laboratory exception events (e.g. investigations, deviations, CAPA), change control, test methods, and specifications; ability to coach and train cross-functional colleagues (AD and QC) to ensure cGMP compliance to these specific areas.
* Reviews, approves, and coordinates review of validation projects for small molecules and/or large biologics. Prepares and manages team schedule for this activity and tracks to ensure timelines are met.
* Proficient in and maintains awareness of laboratory controls per FDA and EU cGMP guidelines.
* Expertise in leading daily QA team activities including planned changes, deviations, investigations, and provides on-going support and training to more junior staff members in these areas.
* Reviews and approves AO validation efforts from phase 1 through commercial and highly experienced in method validation and method transfer guidelines per ICH and USP.
* Reviews and improves existing quality procedure workflows, identifies areas of improvement for efficiency and compliance, and leads implementation efforts in collaboration with cross-functional stakeholders.
* Serves as QA project lead, leads complex quality investigations/deviations, and independently authors or 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.
*Possesses several years of practical experience in a pharmaceutical GMP analytical testing laboratory focusing in validation.
* Bachelor s degree in chemistry, biology or related scientific field. M.S. is preferred.
* Expertise in Quality Systems and cGMP standards applicable to clinical and commercial products and AO/QC laboratory operations.
* Prior participation in regulatory inspections and knowledge of FDA, ICH and European regulations are desirable pertaining to validation of analytical methods.
* An accountable team player and leader 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.
* Proficiency in phase appropriate validation of small molecules, biologics and solid oral dosage forms is required.
* 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) on a daily basis.
* Advanced technical writing and excel skills are highly desired for creating and presenting reports.
* Ability to work independently and effectively coach peers in a high-paced environment with tight timelines, while maintaining accuracy and quality.
* Ability to effectively generate metrics, and present; data, findings, and improvement initiatives/projects to QA and cross-functional leadership.
* Proficient in data acquisition and LIMS systems such as Empower and Labware is highly desired.
* A relevant background in Quality Control or Analytical Development with a role as a supervisor or manager is highly desired.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications.
May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
May assist or lead compliance audits as required. May interface with regulatory agencies as required.
Interfaces with contract manufacturers to address documentation and compliance issues.
KNOWLEDGE, EXPERIENCE AND SKILLS
Proficient in GMPs and/or GLPs.
Proficient in application of QA principles, concepts, industry practices, and standards.
Demonstrates ability to effectively manage multiple projects/priorities.
Has proven analytical and conceptual skills.
Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
Demonstrates excellent verbal communication, technical writing and interpersonal skills.
Demonstrates working knowledge and good proficiency in Microsoft Office applications.
Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
7+ years of relevant experience in a GMP environment related field and a BS or BA.
5+ years of relevant experience and a MS.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
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