Manufacturing Specialist 2 at Illumina, Inc. in San Diego, California

Job Description:

This is a 1st Shift Position: 6:00 AM-2:30 PM (Monday-Friday)

Position Summary:

We are seeking a motivated and self-directed Manufacturing Specialist with knowledge in FDA regulation to join our Reagent Formulation Manufacturing group. The ideal candidate will have knowledge of GMP, multi-tasking and basic chemistry such as dilution and In-Process testing. This is a great opportunity to work closely with a team and see your work making a direct impact on human health.

Responsibilities:

• Perform all duties as Manufacturing Specialist 1


• Perform Analytical testing on reagents when required with minimal troubleshooting ability.


• Function as an entry level Department Water spider when needed and be aware of teammates activities and prevent potential issues


• May Investigate material discrepancies and resolve issues as needed with assistance from other departments


• Identify discrepancies or gaps in production process and work with engineering team to correct


• Evaluate 6S, Safety and Process to continually develop manufacturing process improvements


• Provide inputs for review, interview applicants and report potential problem areas in employee performance


• May Train employees and ensures job performance meets or exceeds standards when needed.


• Quality Control of reagents and routine data analysis


• May Support engineering prototype build phase

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.

Requirements:

• Experience working within FDA/ISO regulated industry is required


• Experience in analytical testing is a preferred


• Knowledge of a variety of lab equipment and their operation is required.


• Able to carry out experiments following established guidelines and summarize results accurately.


• Experience with SAP and Camstar is a significant plus


• Experience with Non-Conformance Report is highly preferred


• Accurate and timely data evaluation skills and attention to detail


• Team oriented with excellent communication skills


• Excellent cross-functional collaboration


• Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint) a plus


• Ability to apply medical device quality system requirements (21 CFR 820, ISO 13485, etc.) to manufacturing processes and documentation

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

Experience/Education:

• Related Bachelor’s degree preferred – 2 to 4 year of related experience minimum.

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 accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

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