Quality Lead Technical Operations

Quality Lead Technical Operations needed for a contract opportunity for Yoh Scientific’s client located in the Seattle, WA and Devens, MA area. This position is with a major pharmaceutical company that makes cancer and immunology drugs.  If you meet the requirements, please apply to this job  (Job#325215)

12 months w2 contract
Pay rate: $50-$57/hour
Position is 100% on site either Seattle WA, Summit NJ, Devens MA

This position is responsible for leading Product Quality Complaint (PQC) investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with the reported PQCs. This position will lead root cause analysis sessions with site SME’s and determine the associated corrective action to prevent the PQC from recurring.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Education: Degree in biology, chemistry, engineering or other related field.

Experience 2+ year’s relevant industry experience in a cGMP/FDA regulated environment, preferably 2 years Quality experience with one or more years of experience within Quality Systems.

Primary responsibilities include:
? Author, review, and approves Product Quality Compliant (PQC) investigations.
? Ensure proper intake, initiation, evaluation, and investigation of PQC(s), provides input to functional groups during evaluation, investigation, closure and implementation of associated CAPA's
?Contributes to the development and continuous improvement of the PQC process across the Cell Therapy Operations
? Collaborate with cross functional teams (i.e. Scheduling & Cell Logistics , Global Drug Safety, manufacturing sites, etc.) to ensure proper communication and collaboration for PQC(s).
? Support and train cross functional groups with guidance on PQC process to ensure accurate reporting, investigation, root cause analysis and corrective actions.
? Perform routine and ad hoc Quality Systems metric reporting and analysis for the PQC(s) data.
? Prepare metrics and perform periodic trend analysis for PQC(s) in support of CTDO management review.
? Provide communication as to the status of PQC(s) deliverables to management, and stakeholders.
? Act as PQC Subject Matter Expert (SME) to support cross functional groups for PQC(s) intake, investigations, approval, and reporting.
? Support internal, external audits and regulatory inspections such as data gathering, PQC process support and/or other audit support functions as necessary.
? Support corporate requests for compliance and regulatory assessments.

• Equipment Usage During Work Period: Computer 70%; Phone and Electronic Devices 30%.
• Sitting at a computer terminal for an extended period.
• Regular sitting, standing, talking, listening, using hands & fingers to operate a computer and telephone keyboard reach.
• Requirement to work in a conference room / meeting environment for moderate periods of time.
• Occasional periods in labs or production area, requiring some level of gowning.
• Light to moderate lifting.
• Regular, predictable attendance is required, plus occasional overtime, as business demands dictate.
• Moderate noise i.e. business office with computers, phone, and printers.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Opportunity is Calling, Apply Now!

What’s In It For You?

We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

•           Medical, Dental & Vision Benefits

•           401K Retirement Saving Plan

•           Life & Disability Insurance

•           Direct Deposit & weekly ePayroll

•           Employee Discount Programs

•           Referral Bonus Programs

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Salary Range
$91,000.00 - 145,000.00
per Year
Salary range estimated by
Bothell, WA 98021, US
Apply Now