Document Controller, Quality and Compliance

2 weeks ago

Calgary, Canada Psygen Industries Inc. Full time

**PSYGEN LABS INC.**

Designation**:Document Controller, Quality and Compliance**

**Key Responsibilities**:

- Assist in drafting and review of new SOPs and Forms, Protocols, Batch Records, and any other controlled documentation.
- Issuance and tracking of all change controls, deviations, OOS, NCRs, Risk Assessments, protocols according to internal document control procedures.
- Comply with all procedures and ensure that requirements of all regulatory and cGMP codes are met.
- File, maintain, and retrieve paper or electronic quality documents, records, and binders when required and continually improve on records organization and management.
- Scan paper records to create electronic records when required.
- Assist in generating Document Control and Batch Record Review metrics.
- Maintain employee training records.
- Maintain compliance oversight of the training program.
- Maintain approved suppliers list with new approvals and required changes.
- Maintain controlled document Master List and manage departmental SOP reviews.
- Assist with ongoing implementation tasks related to ERP system, including form revisions and continued system testing and verification.
- Ensure all implementation requirements for change controls and CAPAs for deviations are completed before document closure.
- Support operational requirements (quality department backup, form issuance, change control and deviation guidance).
- Issuance and tracking of logbooks and batch records.
- Support label control program to assure compliance.
- Other tasks and projects as assigned by the Quality Assurance Manager.

**Qualifications and Experience**:

- Excellent written and verbal communication skills
- Exceptional organizational skills
- Advanced computer skills (MS Office 365)
- 2-3 years pervious document control experience with preference being given to those with cGMP pharmaceutical industry experience.
- Ability to handle a high workload with competing priorities.
- Motivated team player with outstanding interpersonal skills.

**Salary**: $60,000.00-$75,000.00 per year

**Benefits**:

- Casual dress
- Dental care
- Extended health care
- Life insurance
- Paid time off
- Stock options
- Vision care
- Wellness program

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Calgary, AB T2A 7X1: reliably commute or plan to relocate before starting work (required)

**Experience**:

- Document Control: 2 years (required)

Work Location: In person

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