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 Title:

　　Commercial Quality Assurance Inspector

　　Locations:

　　Mississauga, ON

　　Business Type:

　　Commercial

　　Department/Function:

　　Quality

　　Reports to:

　　Compliance and QA Inspector Supervisor

　　FLSA Status:

　　Hourly

　　Prepared By:

　　Sharlett Burgess

　　Approved By:

　　Sharlett Burgess

　　Summary of Objective:

　　Responsible for achieving quality standards during the production process. Monitors production for compliance to customer specifications, GMP, pharmaceutical standards and internal SOP’s. Performs line audits, final inspections as well as Line Clearance verifications. Responsible for pulling and labeling client requested samples (i.e., stability). The QA Inspector role reports to the Compliance and QA Inspector Supervisor.

　　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. Partners with Operations Personnel (i.e., Operations Manager, Production Supervisor, Production Line Leaders, Packagers, Maintenance Supervisor, Mechanics) and Quality Assurance Personnel (i.e., QA Associates) in assessing product quality. Involved in start-up challenges and verification of correct lot/expiry date prior to start of the run. Performs line audits during shift to ensure PBR and SOPs are being followed. Conducts sampling routines Evaluates finished goods and recommends the approval or rejection of work accordingly. Communicates issues and production problems to Operations Personnel and Quality, Assurance Personnel. Makes suggestions and helps where appropriate, to ensure production is expedited. Acts as a line of communication between the Packaging Rooms and the Compliance and QA Inspector Supervisor. Assists in the investigation and resolution of quality problems. Undertakes the writing, revision, and documentation of SOP’s. Responsible for educating Operations Personnel (i.e., Production Supervisor, Line Leaders, Packagers and Mechanics) in SOP’S. Assists the Compliance and QA Inspector Supervisor with the development of policies, procedures, and work practices. Assists the Quality Director and Compliance and QA Inspector Supervisor with audits as requested. Performs Line Clearances. Responsible for approving completed logbook pages as required. Checks and records room pressures on a daily basis Responsible for monitoring and adhering to safety practices, raising concerns or issues to the appropriate level. Back up support to the various functions of the QA Team as required This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position. Performs other duties as assigned by Manager/Supervisor.

　　Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

　　Stationary Position: From 1/2 to 3/4 of the day.

　　Move, Traverse: Up to 1/4 of the day.

　　Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up.

　　Install, place, adjust, apply, measure, use, or signal: 3/4 of the day and up.

　　Ascend/Descend or Work Atop: Up to 1/4 of the day.

　　Position self (to) or Move (about or to): From 1/2 to 3/4 of the day.

　　Communicate or exchange information: 3/4 of the day and up.

　　Detect, distinguish, or determine: 3/4 of the day and up.

　　On an average day, the individual can expect to move and/or transport up to 50 pounds

　　between 1/4 and 1/2 of the day.

　　This position may have the following special vision requirements.

　　Close Vision ☒ Distance Vision ☒ Color Vision ☒ Peripheral Vision ☒ Depth Perception

　　Ability to focus ☐ No Special Vision Requirements

　　Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

　　The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

　　Extreme cold (non-weather) for up to 1/4 of the day.

　　Toxic or caustic chemicals for up to 1/4 of the day.

　　Work near moving mechanical parts for 1/4 to 1/2 of the day.

　　37TThe noise level in the work environment is typically, moderate.

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

　　Required:

　　Post-secondary education in business administration or related field

　　Minimum 1 to 3 years’ experience in an administrative support role, preferably in the pharmaceutical or packaged goods industry

　　Technical writing skills

　　Excellent communication skills (oral and written)

　　Computer knowledge to use software programs such as Microsoft Office, proprietary software programs, internet navigation, ERP etc.

　　Proficiency with the English language

　　Strong aptitude for figures

　　Excellent time, project management, attention to detail and negotiation skills

　　Excellent interpersonal and organizational skills

　　Excellent team player to with the ability to effectively participate in team meetings

　　Must be able to work with limited supervision

　　Demonstrated commitment to our fundamental principles of integrity, respect and excellence

　　Preferred:

　　Ability to exhibit sound and accourage judgment.

　　Ability to demonstrate attention to detail.

　　Ability to display excellent time management skills.

　　Ability to work independently and/or as part of a team.

　　Knowledge and experience with manufacturing processes and products.

　　Knowledge of GMP and pharmaceutical standards an asset.

　　#LI-KH1

　　Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

　　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.

　　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 how.

　　PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled