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27 days old

Quality Assurance (QA) Manager - Pharma / APIs

Kelly Services
Oceanside, CA 92054
**Quality Assurance (QA) Manager - Pharma / APIs, Oceanside, CA**



**Basic Objective:** The QA Manager leads the Quality Assurance and Compliance functions at manufacturing facility. This role is fully accountable to apply a combination of managerial tasks, supervision and Good Manufacturing Practices (i.e.: ISO 9001 and ICH Q7) in a manufacturing environment to quickly assess facts and make the appropriate decision when process/product quality may be impacted.



**Essential Duties and Responsibilities:**




+ Manage, organize, oversee, and ensure that the objectives of the Quality Assurance function are implemented in line with the Corporate Quality and business goals.

+ Develop, manage, and maintain the Quality Management System to meet applicable Regulatory requirements and International Quality Standards.

+ Ensure products meet customer quality expectations and requirements.

+ Direct and oversee all department staff in the performance of their respective duties, and complete related HR activities, including interview, disciplinary and performance management tasks.

+ Identify needs for, and provide training, development and support for all staff.

+ Ensure products are tested and released in accordance with approved specifications and procedures.

+ Initiates, investigates, reviews and approves non-conformances, failure investigation reports and corrective / preventive actions (CAPA), and develop strategies for continuous improvement.

+ Analyze and present related reports, data and Key Performance Indicators for management and executive review as requested.

+ Direct and participate in the management and maintenance of the internal and external audit programs. Ensure that the audits are completed in an accurate and timely manner. Serve as main point of contact and participant in customer audits and regulatory inspections.

+ Ensure maintenance of procedures relating to Quality Assurance, Quality Control, Materials Management, Manufacturing, Compliance, and other functions.

+ Maintains the systems for handling and evaluating customer complaints, product returns/recalls, equipment and training requirements.

+ Work in conjunction with other internal departments and external customers as appropriate, ensuring that the executive management is informed of serious quality issues.

+ Maintain the Company's established Quality Management System (QMS) and certifications per ISO 9001 and ICH Q7 GMP requirements.

+ Direct management of on-the-floor QA activities including but not limited to batch record review, deviation investigation, change controls, order fulfillment and SOP, among others.

+ Strategic advisor to senior management of quality, compliance, supply and safety risks.

+ Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities.

+ Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement.

+ Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback.



**Job Requirements:**




+ Bachelor's degree in Science (Biochemistry / Chemistry preferred) with 5-10 years of QA experience working in a GXP or ISO regulated environment.

+ GMP experience in a manufacturing environment required.

+ Managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.

+ Must have excellent skills in organization, negotiation, problem solving, oral presentation, technical writing and time-management.

+ Able to attend to detail and act decisively.

+ Ability to work under pressure with changing priorities, manage several tasks at once and meet tight deadlines.

+ Ability to work extended hours and/or weekends to support Production and Quality Control activities.

+ Validated expertise in Quality Systems such as Non-Conformance, CAPA and Change Control.

+ Experience with internal audits.

+ Experience with Validation of GXP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment / GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per compliance requirements

+ Ability to motivate staff and manage and distribute workloads.

+ Demonstrate ability to interact with customers and/or regulatory agencies.

+ Ability to evaluate compliance issues.

+ Proficient in Microsoft Word, PowerPoint, Access and Excel.






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll 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 careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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
Posted: 2019-10-18 Expires: 2019-11-18

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Quality Assurance (QA) Manager - Pharma / APIs

Kelly Services
Oceanside, CA 92054

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