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Senior QA Associate, San Diego, CAThe Senior Quality Assurance (QA) Associate will have responsibility for performing a variety of tasks related to Quality Assurance systems and compliance programs supporting GMP site activities. The position requires experience working in GMP regulated environments and practical knowledge in FDA and international regulatory requirements as applicable to development and investigational phase products.Essential Duties and Responsibilities:
Assists in reviewing, processing, and maintaining company's Document Control system through:
Organization and maintenance of controlled documents.
Writing, reviewing/revising, approving, and processing Standard Operating Procedure (SOP), Batch Record, Protocol, and equivalent documents through the Document Control system.
Issuance of document, part, lot, and investigation numbers.
Issuance and review of electronic and paper-based GMP logbooks.
Assists with continually evaluating Quality Systems and procedures while independently identifying areas for improvement and assisting in the implementation of new practices.
Assists with reviewing, processing, and maintaining the training program.
Provides GMP training to cross-functional departments.
Coordinate, perform, and track internal audits.
Coordinate, perform, and track external audits.
Coordinate, perform, and track risk assessments.
Assists with customer communication and customer audit processes.
Writes, reviews, and approves discrepancy reports (e.g. deviations, CAPAs, complaints, etc.).
Performs regular follow-ups and tracks discrepancy reports to closure.
Assists with executing and maintaining Electronic Management Systems as it relates to Quality.
Issue and review labels used for GMP processes.
Assists with generating and providing Quality metrics for review.
Performs other related duties as assigned.
General Responsibilities:
Operates to the highest ethical and moral standards.
Complies with company¿s policies and procedures.
Adheres to quality standards set by regulations and company's policies, procedures and mission.
Communicates effectively with supervisors, colleagues and subordinates.
Ability to participate effectively as a team player in all aspects of company's business.
Demonstrate administrative leadership with knowledge-based expertise in related areas that can be applied to meeting company's strategic goals.
Travels as needed to attend audits, professional conferences, and training opportunities.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Job Requirements:
Bachelor's (BS / BA) degree in a relevant life sciences discipline or equivalent.
Minimum of four (4) to six (6) years' experience in a GMP oriented environment and Quality Assurance.
Knowledge of GMP regulations, good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards and guidance.
Knowledge of industry standards and regulation requirements for biologics and paternal products in clinical development.
Ability to analyze with proficiency in the application of problem solving and root cause analysis methodologies.
Skill in writing to effectively communicate complex ideas and concepts.
Detail oriented with strong analytical, written, and verbal communication skills.
Must be familiar with Microsoft Office applications.
Ability to work well under pressure, independently, multi-task, be organized and have good communication skills.
For Immediate Consideration, Apply Today! Questions? Call Alex at 858.207.6311.Why Kelly ® ?With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.About Kelly ®At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
