Document Control Associate

1 month ago

Mississauga, Canada Contract Pharmaceuticals Full time

**WHO WE ARE**:
At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and semi-solid pharmaceutical products domain, and ultimately bring benefits to the customers using our manufactured products.

For more than 30 years CPL has partnered with the world’s leading pharmaceutical companies to provide full-service product development and manufacturing, singularly focused on innovation and efficiency.

We recognize our employees are our number one asset and support their career growth. We also offer a benefits program which includes Health/Dental and Vision care, deferred profit-sharing plan, paid time off, employee’s assistance program, work/life balance, employee recognition program, on-site parking, discounted gym membership and wellness program.

**PURPOSE OF THE CONDITIONS**:
Responsible for receipt, archival, control, and retrieval of controlled GMP documents at the Danbro campus, Meadowpine campus, and the off-site storage facility as per regulatory requirement and site procedures. Maintain the Document Archive Inventory Log. Manage the disposition of controlled GMP documents in alignment with retention schedule requirements. Support audits and inspections with timely documentation retrieval and readiness.

**SPECIFIC RESPONSBILITIES**:

- Receive, archive, control and retrieve controlled GMP documentation.
- Accurately prepare documentation for storage both on-site and off-site.
- Accurately maintain the Document Archive Inventory Log to reflect the storage location for each controlled GMP document.
- Retrieve archived documents in a timely manner based when requested.
- Ensure retrieved documentation is fully traceable by a documented log out / log in process.
- Adhere to retention schedule requirements to support the timely disposition of documentation for space and cost efficiency.
- Manage the process to perform timely disposition of documents that have reached the end of the retention period by shipment of documents to Clients or destruction of Client / Site documentation (obtain client approvals when required).
- Support Client Audits and Regulatory Inspections.
- Respond to regulatory, client, or internal requests for document information and to general questions pertaining to document control procedures.
- Follow CPL Safety, GMP and Department SOPs.
- Issue and reconcile logbooks.
- Work with the teams to ensure custody of original GMP documents/records.
- Maintain, organize and scan GMP documents/records as required.
- Maintain a clean workplace.
- Upholding CPL values: Excellence, Rigor, Ownership, Integrity and Agility.
- Other duties as assigned.

**QUALIFICATIONS**:

- College diploma in a science field; Bachelor of Science degree is preferred.
- Strong working knowledge and experience with Microsoft Office 365.
- Excellent verbal and written English communication skills.
- Flexible with the ability to adapt, respond quickly and manage change in a fast-paced environment.
- Previous experience in a GMP environment or administrative function involving document filing / archiving is an asset.
- Knowledge and experience with TrackWise is an asset.

**PHYSICAL DEMANDS AND WORKING CONDITIONS**:

- General office work environment (walk, sit, or stand for limited periods)
- Regular movement of files, binders and boxes of documentation.
- Ability to handle boxes up to 20lbs containing documents / records.

We thank all applicants for their expression of interest; however, only those selected for an interview will be contacted. No phone calls or agencies please.

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