Senior QA Associate

JOB SUMMARY  Responsible for applying and maintaining quality standards for PCI Pharma Services and products. Responsible for the maintenance and performance of all quality management systems. Works closely with production and customer service to ensure customer specifications are met and comply with internal operating standards and regulatory standards (GMPs). Reports to the Quality Director.

ESSENTIAL DUTIES AND RESPONSIBILITIES   Consistently applies company SOP’s relative to production, quality, and pharmaceutical standards
Reviews and approves executed inspection and production-related documentation
Guides, coaches, and directs production staff with respect to Quality issues and concerns using collaborative problem-solving skills
Compiles and maintains QA documentation and data
Consistently evaluates PCI quality control methods, policies, etc. and makes recommendations for improvement
Prepares Deviation/Incident Reports
Investigates customer complaints and provides a detail report to client outlining results of investigation
Reviews IORFs and determines type of documentation required to support the incident
Annual Product Assessments as required by clients
Responsible for monitoring and adhering to GMP as well as Health and Safety
Practices under the Occupational Health and Safety Act, raising concerns or issues to the Sr. QA Associate and/or Quality Director
Conducts training on PCI’s Quality Management Systems, processes and performs annual GMP refresher training
Conducts environmental monitoring of Production Areas
Investigates temperature and humidity excursions in GMP areas
Performs weekly assessments of temperature and humidity reports
Assists Quality Director with external audits
Assists with responses to external, internal, and Regulatory audit observations
Undertakes quality control inspections, line clearances and line audits as required
Approves material requisition forms for packaging, destruction, QA samples, rejects and any adjustments of pharmaceutical components and/or end use products
Performs new product assessment to determine if new product (API) can be primary or secondary packaged at our site
Lead, measure, and assess the procedures associated with the initiation and reporting of deviations, complaints, self-inspections and CAPA’s
Initiate CAPA’s resulting from deviations, customer complaints, identified non-conformances, audits, or any other means of problem identification
Ensure resolution of corrective actions is accomplished in a timely manner using sound methods for root cause analysis, short term containment, and permanent solutions
Communicate the status, results, and impacts of corrective actions to the appropriate stakeholders
Ensures products and processes conform to SOPs, documented procedures, and expected quality levels
Develop, monitor, and publish quality metrics that will accurately represent the performance levels as they relate to deviations, complaints, CAPA’s, self-inspections
Assess procedures currently in place for compliance
Identify gaps and make recommendations on improving compliance
Manages the storage of retained samples
Revise GMP documentation (SOP’s, Forms, etc) via the change control system
Develops test standards and procedures
Assigned delegated Sr. QA Associate Responsibilities and acts as a back-up to Sr. QA Associate and Quality Director as required
Responsible for other duties as required
SKILLS, KNOWLEDGE / EXPERIENCE REQUIRED TO PERFORM THE JOB   Consistently applies company SOP’s relative to production, quality, and pharmaceutical packaging.
University degree /college certificate and 2-5 years of equivalent experience in the fields of math or science.
Experience in the pharmaceutical industry and knowledge of GMP’s.
In-depth knowledge and experience…