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 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 mathematical as well as written and oral communication skills.
• The ability to oversee project assignments, direct daily activities and provide on the job training to temporary employees.

MENTAL EFFORT REQUIRED TO PERFORM THE JOB

Concentration and intense visual discernment during the scrutinizing and proofing of work in process. Attention to detail when utilizing the PC and data entering information. Mental attentiveness and professionalism with providing commentary or co‑ordinating people and tasks. Requires an ability to multitask.

PHYSICAL EFFORT TO PERFORM THE JOB

Requires a significant amount of walking and standing on a concrete floor. Works at a computer terminal for long periods of time entering and analyzing data.

SUPERVISION

Reports to the Quality Director. Established work schedule based on production needs.

WORKING CONDITIONS WHILE PERFORMING THE JOB

Works in climate-controlled office (70%) and warehouse and packaging rooms (30%). Works with frequent interruptions both in person and by telephone.

The salary for this position is $59,840 -$67,320 CAD, with eligibility for an annual performance bonus. The final offer will be determined by a variety of factors, including but not limited to relevant experience, education, professional designations, specialized skills, and work location.

This posting is for an existing vacancy currently open and available for hire. PCI provides full-time employees in Canada with a comprehensive and competitive benefits package, which includes paid time off, extended health benefits (including dental and vision), life and disability insurance, and retirement savings options such as an RRSP with employer contributions. Additional wellness and employee-support programs may also be available.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out no.