Job details
Salary $59 - $60 an hour job type full-time contract number of hires for this role on-going need to fill this role
Full job description
Job description: position is 100% on site either seattle wa, summit nj, devens ma
Purpose and scope of position:
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 expectationsThis position will be responsible for operating cross-functionally, collecting necessary data and information associated with the reported pqcsThis 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.
Duties and responsibilities:
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.eScheduling & 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.
Working conditions (us only):
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.eBusiness 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 positionThe 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 positionThere are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this jobEmployees holding this position will be required to perform any other job-related duties as requested by management.
Additional job requirements:
None
Contract length: 6 months
Job types: full-time, contract
Salary: $59.00 - $60.00 per hour
Schedule:
8 hour shift
Work remotely:
Yes
