QA Associate

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

1st shift:
Summary of Objective:
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
- Consistently applies company SOPs relative to production, quality, and pharmaceutical standards.
- Reviews and approves executed inspection and production-related documentation.
- Guides, coaches, and directs production staff concerning 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 detailed report to clients outlining the results of the investigation.
- Reviews IORFs and determines the type of documentation required to support the incident.
- Performs 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, and processes and performs annual GMP refresher training.
- Conducts environmental monitoring of Production Areas.
- Investigate temperature and humidity excursions in GMP areas.
- Performs weekly assessments of temperature and humidity reports.
- Assists the 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 CAPAs.
- Initiate CAPAs resulting from deviations, customer complaints, identified non-conformances, audits, or any other means of problem identification.
- Ensure resolution of corrective actions is accomplished promptly 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, CAPAs, and 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 (SOPs, Forms, etc.) via the change control system.
- Develop test standards and procedures.
- Assigned delegated Sr. QA Associate Responsibilities and acts as a backup to Sr. QA Associate and Quality Director as required.
- This position may require overtime and/or weekend work.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
- Attendance to work is an essential function of this position.
- Performs other duties as assigned by Manager/Supervisor.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

Required:

- Consistently applies company SOPs relative to production, quality, and pharmaceutical packaging.
- University degree /college certificate or equivalent experience in the fields of math or science.
- Experience in the pharmaceutical industry and knowledge of GMPs.
- In-depth knowledge and experience with manufacturing and packaging processes.
- Exceptional attention to detail and accuracy in the maintenance of records and data.
- Excellent organizational and time management skills to ensure deadlines are met.
- Effective interpersonal and teamwork skills.
- The ability to problem solve, coach as well as influence and negotiate at all levels within the organization.
- Extensive computer knowledge and adeptness with various software programs including Microsoft Word, Excel, Outlook, and Database Management.
- Excellent