Senior QC Laboratory Specialist - 2nd Shift

The Senior QC Laboratory Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards.

This role is responsible for generating test methods, reports, and specifications for raw material, in-process, and finished goods in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to: investigating failures, executing validation protocols, and troubleshooting calibrated equipment.

Assists and trains Lab Techs and Specialists.
Performs product and raw material testing of samples.
Prepares of reagents, standard solutions, equipment for use, etc.
Recognizes and communicates unexpected results in a timely manner and completed Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials.
Writes and revises standard operating procedures (SOPs) under supervisor's direction, using Quality software to change, submit and review documents.
Assists in writing validation protocols and reports.
Supports and/or develops chemical testing procedures.
Supports and/or develops technical requirements for raw material specifications based on input from potential vendors, product development staff, and process engineering.
Coordinates Failure Investigations by designing and performing lab scale simulation of products made in the plant.
Troubleshoots & calibrates Lab equipment.
Maintains and orders lab supplies.

Required:

• Bachelor degree
• Minimum 4 years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) required.
  Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer:

* Market Competitive Pay with shift differential
* Extensive Paid Time Off and (9) added Holidays
* Excellent Healthcare, Dental and Vision Benefits
* Long/Short Term Disability Coverage
* 401(k) with a company match
* Maternity and Paternity Leave
* Additional add-on benefits/discounts for programs such as Pet Insurance
* Tuition Reimbursement and continued education programs
* Excellent opportunities for advancement in a stable long-term career

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