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Quality Specialist

Company: Thermo Fisher Scientific Inc.
Location: Riverside
Posted on: May 3, 2021

Job Description:

Job Description

Job Description

Job Title: Quality Specialist

Reports To: Manager, Quality

Job Profile: Sr QC Technician

Group/Division: LSG, BPD

Career Band: 3

Job Track: Associate

Position Location: Riverside, CA

Number of Direct Reports: 0

Day/Shift (if applicable): Day

FLSA Status (Exempt/Non-Exempt): Non - Exempt

Relocation (if applicable): No

Position Summary:

The Quality Specialist is part of the Quality Systems team and is responsible for all functions related to raw material sampling at a facility providing sampling services as well as other identified quality related activities required to support delivery of PCS Supply Chain Services. This job requires strict adherence to cGMP /cGDP guidelines. Under the direction of Quality Manager and in coordination with the applicable Site Manager, the Quality Specialist is responsible for the execution of daily sampling and other quality activities to meet and exceed our customer requirements for safe, accurate, and cGMP compliant raw material sampling and related PCS Supply Chain Services. This position will also support the Quality Manager with other Quality Management System elements as required.

Key Responsibilities:

  • Understand and comply with PCS safety policies and procedures in the warehouse by completing the safety and accident preparedness training outlined in the Production Chemicals & Services Safety Center. Bring potential safety issues to the attention of the Quality Manager, Site Manager, Regulatory Compliance EHS&S Sr. Manager and or designee.
  • Coordinate with the warehouse staff/warehouse lead to execute the materials movement activities needed to support the raw material sampling execution according to PCS Quality Procedures.
  • Ensures timely execution of all raw material sampling, documentation, preventative maintenance activities and processes in an efficient and cGMP compliant manner.
  • Maintain all Quality records, (i.e. sampling documentation, logbooks, calibration certificates, et al.), in an audit ready state at all times to support the PCS Quality Management System.
  • Clean, stock and maintain the raw material sampling cleanroom suite, consumables, equipment and instruments according to the relevant PCS Quality Procedures. Document all relevant activities as required.
  • Keep up to date with all required job-related, cGMP/cGDP and safety training requirements and train additional PCS staff in support of the raw material sampling process as needed.
  • Follow all applicable standard operating procedures related to the raw material sampling execution as well as performing maintenance activities to support a compliant cleanroom operation.
  • Maintain accurate data entry, key process indicators (KPIs)/process metrics, spreadsheets, et al. to support the Quality Manager and PCS Quality Management.
  • Perform quality related activities such as product quality inspections, labeling, etc. associated with supply chain services to ensure customer service models are executed according to PCS work instructions. Sampling will be the main essential priority for this role and other activities will be executed during periods of non-sampling activities.
  • Utilize 6-sigma and LEAN tools to improve processes and reduce waste throughout the Quality Management System.
  • Ability to apply practical process improvement (PPI) in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
  • Additional responsibilities as assigned/required by the QM.

Minimum Requirements/Qualifications:

  • Learn and execute ISO 9001 PCS Quality System Procedures, Work Instructions and cGMP guidelines related to this position's duties and responsibilities and be compliant at all times.
  • Basic knowledge of quality standards and regulations (e.g., 21 CFR Part 210,211, ISO 9001, IPEC, USP 1079).
  • Demonstrate a positive and collaborative approach in supporting customers and department objectives.
  • Ability to effectively partner with key stakeholders including Operations, Account Services', Procurement, Quality Specialists and Customers.
  • Have a "Customer Service" approach to relationships with internal and external parties with the capability to leverage and flex diverse resources, respond quickly, build collaborative relationships and focus on customer needs.
  • Completes required tasks in timely and accurate manner and stays on task.
  • Honor commitments, treat others with dignity and respect, communicate openly and encourage feedback, be accountable for successes and failures, and be a role model by exemplifying the 4I values.

Required Qualifications

  • Bachelor's Degree (Chemistry or related science) or suitable education in an appropriate specialty is preferred. Minimum of a High School diploma with tow or more years of relevant experience.
  • Minimum of 2 years of experience in a cGMP controlled environment such as biopharmaceutical manufacturing, raw material sampling, environmental monitoring and/or quality assurance.
  • Raw Material sampling experience is strongly preferred.
  • Ability to work in a fast pace environment while following all applicable procedures and PCS safety policies.
  • Excellent verbal and written communication skills.
  • Proficient computer skills including email, word processing, spreadsheets, database and internet applications.
  • Demonstrate willingness and ability to work collaboratively with Quality Specialist, Quality Management and other departments (e.g. Warehouse, Account Services', etc.) to complete all quality responsibilities.
  • Must be able to stand, squat, stoop, lift, handle hazardous/non-hazardous material, wear a respirator when applicable and pass an annual respirator fit and physical test.

This position has not been approved for Relocation Assistance.

Keywords: Thermo Fisher Scientific Inc., Riverside , Quality Specialist, Other , Riverside, California

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