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Added 2 hours ago
LW
director, facility management
Le Westin Montreal
Montreal, QC
- Full-time
Plan, organize and direct administrative services such as signage, cleaning, maintenance, parking, safety inspections, security and snow removal
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PV
Medical Director & Small Animal Veterinarian
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- Full-time
…team in the capacity of Small Animal Veterinarian and Medical Director. Experienced Medical Directors are preferred, but an experienced Veterinarian with a disposition towards leadership…
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PV
Small Animal Veterinarian
P3 Veterinary Partners
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- Full-time
…searching for a welcoming environment led by an experienced Medical Director that is passionate about progressive medicine, mentorship, collaboration, and empowering…
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S
Social Worker
Sanya’k̓ula
Port Coquitlam, BC
- Full-time
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Added 4 hours ago
S1
Technical Deployment Manager
Signal 1
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- Full-time
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Added 5 hours ago
Manager - Distribution and Transmission Settlements
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KM
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- Full-time
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Added 9 hours ago
LE
Manager of Transportation and Lawn Services
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Wyoming, ON
- Full-time
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Added 9 hours ago
GT
Project Coordinator - Financials
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- $55 CAD / hour
- Contract
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Part time to fulltime Director of Marketing and Sales of Homecare Services in Montgomery and Chester Counties
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- Full-time
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Added 15 hours ago
PP
Senior QA Associate
PCI Pharma Services
Mississauga, ON · CAN_Mississauga
- Full-time
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…
Added 15 hours ago
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- Full-time
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- Full-time
…responsible for providing clinical and consultative social work services of a general nature to the defined client populations with complex concurrent disorders and their families and…
Added 23 hours ago
PH
Social Worker
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…responsible for providing clinical and consultative social work services of a general nature to the defined client populations with complex concurrent disorders and their families and…
Added 23 hours ago
PH
Social Worker
Provincial Health Services Authority
Surrey, BC
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…responsible for providing clinical and consultative social work services of a general nature to the defined client populations with complex concurrent disorders and their families and…

PCI Pharma Services

Senior QA Associate

Mississauga, ON, Canada
CAN_Mississauga, Canada

Full-time

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Job details

Job type: Full-time
Experience: University degree /college certificate and 2-5 years of equivalent experience in the fields of math or science.
Posting language: English
Posted: Oct 12, 2026

Original job description

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.

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

o Manages the storage of retained samples

o Revise GMP documentation (SOP’s, Forms, etc) via the change control system.

o 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 al 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 REQUIREDTO 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.

This posting is for an existing vacancy currently open and available for hire.

At PCI, we do not use AI within our hiring practices.

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More about this job

Responsibilities

The Senior QA Associate is responsible for maintaining quality management systems and ensuring production processes comply with GMP standards and customer specifications. They lead investigations into deviations and complaints, manage CAPA initiatives, and provide training on quality procedures.

Requirements

Candidates must possess a university degree or college certificate in math or science along with 2-5 years of relevant experience in the pharmaceutical industry. Strong knowledge of GMPs, excellent attention to detail, and proficiency in data management software are essential for this role.

Skills

Quality management systems
GMP
SOP compliance
Documentation review
Problem-solving
Data analysis
CAPA
Deviation reporting
Environmental monitoring
Audit support
Root cause analysis
Quality metrics
Pharmaceutical packaging
Time management
Microsoft Office
Training

Benefits

Paid time off
Extended health benefits
Dental insurance
Vision insurance
Life insurance
Disability insurance
Retirement savings options
RRSP with employer contributions
Wellness programs
Employee-support programs

Visa sponsorship

Not detected in the job text

Keywords

Quality Assurance
GMP
Pharmaceuticals
SOP
CAPA
Deviation
Quality Management Systems
Compliance
Audit
Packaging
Root Cause Analysis
Environmental Monitoring
Data Entry
Documentation
Quality Control
API
Health and Safety
Metrics
Change Control
Database Management
Microsoft Word
Microsoft Excel
Microsoft Outlook
Line Clearance
Inspection
Training
Biopharma
Regulatory Standards
Incident Reports
Product Assessment

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