Manager, QC Analysis at Illumina (San Diego, CA)

| San Diego, CA
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What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world-changing projects, you will do more and become more than you ever thought possible.

The Manager, QC Analysis/Transfer Support, oversees the support activities required for new product transfers into the Reagent QC operations. The manager also supports the transfer of products and the associated QC test method(s) to other sites. The manager will directly oversee a team of QC Analysts on a fast-paced team and will be responsible for ensuring the timely execution of transfer deliverables.

  • Oversee a team of high performing QC operators supporting the transfer of new test methods into QC as well as the transfer of legacy methods to other sites
  • Serve as main point of contact from Reagent QC for the Method Development and Transfer (MDT) and Site Transfer teams for the coordination of transfer deliverables, including PPQ activities, QC documentation review, and training
  • Schedule and coordinate resources to ensure transfer deliverables are executed in a timely manner
  • Track QC status of NPI and Site Transfer projects; coordinate with NPI teams, MDT, Site Transfer, and Reagent QC to deliver results
  • Support the other Reagent QC sub-teams (Library Prep, Sequencing, Analytical) with product release testing when needed
  • Participate in internal and external audits, as necessary, to represent Reagent QC processes
  • Support talent acquisition activities for new departmental hires, including interviewing, onboarding, and training
  • Lead performance management activities, including coaching and feedback, quarterly check-ins, and individual development plans, as needed
  • Other duties may be assigned as determined by management

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

  • 5+ years of experience in Quality Control, preferably in a regulated, high complexity testing environment
  • 2+ years of leadership experience is desired
  • Knowledge of test method transfer process, including process performance qualification, verification and validation
  • Knowledge of next generation sequencing workflows helpful, but not required
  • Strong verbal and written communication, interpersonal, and leadership skills
  • Strong organizational skills and attention to detail
  • Ability to multi-task and prioritize duties to meet timelines
  • Experience with GMP operations and production of products for clinical markets
  • Familiarity with business systems such as Laboratory Information Management Systems (LIMS), SAP, document management systems

  • Bachelor's degree required; life science major is preferred; advanced degree (Master's) strongly preferred, in applicable field or equivalent.
  • Typically has 7+ years of direct work experience, with 1-3 years of Management experience.
  • 5+ years of experience in the medical device industry or a related FDA-regulated industry preferred
  • 5+ years of experience in Quality Control or Quality Assurance, with 1+ year in a lead/supervisory capacity preferred

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.

Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, Illumina may require proof of COVID vaccination in accordance with local statutory requirements (subject to limited exceptions) beginning November 1, 2021.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact [email protected] To learn more, visit:
More Information on Illumina
Illumina operates in the Biotech industry. The company is located in San Diego, CA, Madison, WI, Foster City, CA and San Diego, CA. Illumina was founded in 1998. It has 7400 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 35 open jobs at Illumina, click here.
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