QA Systems Specialist III
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POST DATE 9/15/2016
END DATE 1/13/2017
Gilead Sciences, Inc
San Dimas, 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.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
Participates in developing Standard Operating Procedures to ensure quality objectives are met.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
Develops solutions to more complex problems, identifies variance from accepted practice, and evaluates impact as necessary.
Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.
Interfaces with contract manufacturers to address compliance issues.
Normally receives no instruction on routine work, general instructions on new assignments.
Perform data integrity audits for a GMP manufacturing site including GMP QC and Micro test labs, and assign necessary corrective actions and author final reports.
Revise and/or participate in developing SOPs to ensure quality objectives are met.
May perform/support internal audits.
Perform risk assessments on systems to ensure adequate engineering and procedural controls are in place and followed.
Be well versed in industry guidelines (FDA, MHRA, EU, USP, etc.) and provide training when necessary.
Provide QA guidance on data integrity and computerize system issues.
Manage and support during regulatory agency inspection.
Perform QA review of the following:
System lifecycle documents (user requirement specification (URS), functional requirement specification (FRS), configuration specification (CS), detailed specification (DS) and Trace Matrices) for QC laboratory instruments and manufacturing equipment
Commissioning protocols and final reports
Master validation and remediation plans (e.g. Annex 11 and Analytical Method remediation plans and final reports)
Qualification and validation protocols and final reports
QC Method Validations
Authentic Substance and Standard qualifications
KNOWLEDGE, EXPERIENCE AND SKILLS
Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards.
Demonstrates thorough knowledge of FDA / EMEA standards and quality systems and the interface with other functions like manufacturing, distribution and maintenance.
Demonstrates strong verbal, technical writing and interpersonal skills.
Demonstrates proficiency in Microsoft Office applications.
6+ years of relevant experience in a GMP environment related field and a BS or BA.
4+ years of relevant experience and a MS.
Able to independently assess GMP compliance related to internal procedures and policies as well as external regulations such as 21 Part 11, Annex 11, MHRA Guidance, USP, etc.
Be knowledgeable on data integrity concepts as they apply to the system and data lifecycle.
Be knowledgeable with common data software applications such as Empower and LIMS.
Have a strong comfort level with reviewing electronic data and audit trails.
Have strong writing skills.
Must work well in teams.
Must have a strong sense of accountability and urgency when it comes to support project timelines.
Experiences in analytical chemistry, method validation, computer validation, laboratory validation or maintenance are a plus.
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.
For more information about equal employment opportunity protections, view the EEO is the Law poster at :