QA Manager - Sunnyvale, United States - Tailored Management

Description

Position:
Lab Manager


Location:
Sunnyvale, CA

Duration: 12 Months Assignment


Job Description:
We are seeking a highly skilled and detail-oriented Analytical Chemist to join our biocompatibility team at Reality lab.

The ideal candidate will specialize in extractables and leachable analysis by Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS), with a strong focus on sample preparation for consumer electronics and raw materials.

The successful candidate will play a critical role in ensuring the quality, safety, and compliance of our products.


Key Responsibilities:
Conduct extractable and leachable testing of hardware products per ISO10993 standard, perform GC-MS and LC-MS instrument analysis.
Prepare standard solutions, calibration standards for sample identification and quantification.
Develop and validate new methods for the analysis of complex matrices in consumer electronics.

Interpret MS data for unknown compound elucidation based on database search, prepare detailed reports, and make recommendations based on findings.

Collaborate with cross-functional teams to support analytical needs and root cause investigations.
Maintain and troubleshoot analytical instruments to ensure optimal performance.
dhere to all safety and compliance guidelines in handling chemicals and hazardous materials.
Stay abreast of advancements in analytical chemistry, particularly in GC-MS and LC-MS technologies.
Oversee day-to-day lab management, including consumables planning, lab waste management, and scheduling annual preventive maintenance (PM) for instruments.


Qualifications:
Bachelor's degree in chemistry, Analytical Chemistry, or a related field; Master's degree preferred.

Minimum of 2 years of hands-on experience in GC-MS and LC-MS, preferred in a medical device, pharmaceutical or biotech environment.

Proficiency in sample preparation techniques and a strong understanding of chromatography and mass spectrometry.
Demonstrated ability to interpret and report analytical data accurately.
Excellent problem-solving skills and attention to detail.
Strong organizational and time-management skills.
bility to work independently and collaboratively in a fast-paced environment.
Excellent verbal and written communication skills.


Must have skills:

Minimum of 2 years of hands-on experience in GC-MS and LC-MS, preferred in a medical device, pharmaceutical or biotech environment.

Proficiency in sample preparation techniques and a strong understanding of chromatography and mass spectrometry.
Demonstrated ability to interpret and report analytical data accurately.

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