QA lead technical operations

Company: ACS Solutions
Location: Seattle
Posted on: June 24, 2022

Job Description:

QA lead technical operations Location: Seattle, WA Duration: 12 Months Job Description - This position is responsible for providing support for Product Quality Complaint (PQC) investigations, Change Control, and other Quality Systems. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with a number of Quality Systems.This position will facilitate and provide administrative support for meetings related to root cause analysis sessions with site SME's, Community of Practices/Network, Quality Systems team/department. 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. Support other Quality System administration as required. * 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. Degree in biology, chemistry, engineering or other related field. 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.Job Requirements:QA lead technical operations
Location: Seattle, WA
Duration: 12 Months

Job Description -
This position is responsible for providing support for Product Quality Complaint (PQC) investigations, Change Control, and other Quality Systems. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with a number of Quality Systems.This position will facilitate and provide administrative support for meetings related to root cause analysis sessions with site SME's, Community of Practices/Network, Quality Systems team/department.
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.
Support other Quality System administration as required.
--- 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.
Degree in biology, chemistry, engineering or other related field.

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.

Keywords: ACS Solutions, Seattle , QA lead technical operations, IT / Software / Systems , Seattle, Washington