Company: Thermo Fisher Scientific Inc.
Posted on: May 3, 2021
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
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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Keywords: Thermo Fisher Scientific Inc., Riverside , Quality Specialist, Other , Riverside, California
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