SUMMARY/JOB PURPOSE:
The QA Core Associate supports QA Partner in GxP supplier quality management activities, vendor qualification, audit preparation, audit closure, audit observation tracking, vendor retirement, metrics collection, and records management. The position ensures data inputs in the Veeva supplier quality and audit modules and ensure audit logistics in regulatory and partner inspections.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
As QA Core associate, supports QA Partner in:
- Responsible for inputting and maintaining supplier quality and audit-related records throughout the program lifecycle.
- Responsible for obtaining and compiling data relevant to vendor risk assessments.
- Responsible for working independently and cross-functionally in authoring and updating vendor risk assessments that support the supplier quality management program.
- Support Inspection Management activities, including logistics, record management, and inspection readiness activities.
- Maintains and develops reports, templates, SOPs, procedures, and tools, based on regulatory requirements and procedures.
- Meets with internal stakeholders on audit and inspection readiness program.
- Maintains audit and inspection information in the eQMS and supplier quality record repository.
- Support internal and external stakeholders for monitoring vendor performance.
- Help compile and monitor quality metrics related to the supplier quality management and audit programs.
SUPERVISORY RESPONSIBILITIES:
- No supervisory responsibilities
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
- Bachelor’s degree preferably in the life sciences or STEM disciplines and a minimum of one year of related experience
- Equivalent combination of education and experience.
Experience/The Ideal Candidate will have:
- Minimum of 1-3 years of experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience.
- Must have attention to detail and good investigation, problem solving, and organizational skills.
- Administrative experience in organizing and maintaining vendor and audit related records.
- This position requires knowledge and experience with GxP processes related to managing vendors, partners, and suppliers.
- Familiarity with FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 210 & 211, US and EU regulations, ICH guidelines and other industry standards. ISO understanding is a bonus.
- Proven organizational skills to obtain data across multi-functional groups and present results in a consolidated and clear manner.
- Keeps Management informed of the status of assigned projects.
Knowledge/Skills:
- Strong written and oral communication skills.
- Excellent attention to detail and organizational skills.
- Ability to influence decision-makers and utilize sound problem-solving skills to recommend options and implement effective solutions.
- Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
- Ability to contribute to the development of company objectives and key performance indicators.
- Strong user of Microsoft Office applications.
WORKING CONDITIONS:
Facilities/Alameda:
- On-site position
- Environment: primarily working in an office setting
- Essential physical requirements: sitting, standing, and typing.
- Physical effort/lifting; light - up to 20 pounds
#LI-EZ1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $67,000 - $95,000 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
What We Do
Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for more than 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
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For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
