Clinical QA Inspector

7 months ago

Burlington, Canada PCI Pharma Services Full time

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.

The position audits production room packaging activities and documentation at various stages of clinical packaging and ensures samples have been taken at specified intervals. Performs and documents quality inspection activities at receiving, packaging and during distribution.

Essential

**Responsibilities**:

- Responsible for verification of material issuance and reconciliation to packaging operations.
- Verifies copy issuance of batch documents prior to execution.
- Review batch record in real time to ensure compliance with GDP and data Integrity requirements, ensure any non-compliance issues are addressed and any non-conformances observed on the line are raised with QA manager.
- Ensures work is consistent between work orders to maintain clinical blinding requirements.
- Works effectively in a clinical packaging environment that utilizes serialized kit numbers, where one packaging lot is made up of multiple individual packaging lots.
- Manages multiple clinical production lines at the same time, with various types of work order activity.
- Completes in-process verification of paperwork to ensure accuracy and correctness.
- Provides administrative support to the department as required.
- Performs label inspections as required.
- Review sampling pages to ensure samples have been taken, labeled, and documented appropriately.
- Audit production room to ensure Cleaning and Use logbooks have been completed accurately and timely.
- Audit production personnel to ensure the job is performed safely including wearing required personal protective equipment.
- Ensure recovery stations are segregated from product flow (as applicable).
- Review temperature and humidity data to ensure within acceptable job parameters.
- Document audits using the Quality Auditor checklist listing the room, production job description, and date when the audit was conducted.
- Identify proactively gaps in batch records to mitigate deviations and documentation errors.
- May require use of Personal Protective Equipment (PPE) and Powered Air Purifying Respirator (PAPR).
- Support Root Cause Analysis as needed.
- This position may require overtime and/or weekend work.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
- Attendance at work is an essential function of this position. Performs other duties as assigned by Manager/Supervisor.

Qualifications:

- Post-secondary education in science or related field
- Minimum of 1 year experience in operations or quality role, preferably in the pharmaceutical or packaged goods industry
- Proficiency with the English language
- Basic Mathematical Skills
- Excellent time and attention to detail skills
- Excellent interpersonal and organizational skills
- Excellent team player with the ability to effectively participate in team meetings.
- Must be able to work with limited supervision.

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._

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