Quality Assurance Scientist

LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce.

As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.

Job Title : Quality Assurance Scientist

Location : Remote

Duration : 6 Months

Pay Rate : 22 / hr to $24 / hr

Description / Comment :

Complaint Handling Quality Assurance Scientist 1

The Complaint Quality Assurance Scientist I (CHU) position within the Global complaint handling team provides a critical contribution to the overall quality and regulatory compliance of customer complaint investigation.

More specifically they will review, evaluate, and record activities and findings as part of an ongoing global quality process.

This position will follow established procedures to

• Enter and submit complaints on behalf of field-based personnel -
• Ensure supporting documentation is attached to complaints
• Ensure complaints are correctly classified and assign investigators / reviewers
• Design and Perform complaint investigations into the Chemistry / Immunoassay product line
• Conduct reviews of complaint trending to determine CAPA eligibility.
• Escalation of product issues to management.
• Complete the following documents as required :

o Risk assessments

o Stop ship assessments

o CAPA requests

• Represent QA on development, current business or product improvement projects.
• Exercises judgment within defined procedures and practices to determine appropriate action.

Direct communication and collaboration with other functions such as Field Service, Call center, manufacturing, R&D, and other Post Market Surveillance teams will be fundamental to the success of this role.

Ability to follow up effectively will be necessary. Data analysis and problem-solving skills are necessary to identify and countermeasure common failure issues.

Robust documentation and strict adherence to approved procedures are a requirement in the highly regulated work environment.

• Gain and utilize basic product technical awareness to facilitate informed evaluation of customer complaints records being reviewed.
• Complete all needed records in a timely and accurate manner within Smart Solve (compliant management system (CMS)).. Complete all needed records in a timely and accurate manner.

Knowledge / Educational Requirements :

Degree level in a Science or Engineering related discipline

2 years' experience in a laboratory environment or Quality role with previous experience in a CHU environment

Good knowledge of FDA QSR and IS(phone number removed) requirements

Good Troubleshooting skills

To know more about current opportunities at LeadStack, please visit us at

Should you have any questions, feel free to call me on (phone number removed)

Sharif Khan

Senior Recruiter

phone number removed)

611 Gateway Blvd, Ste 120

South San Francisco, CA 94080