Qc Specifications Coordinator

3 weeks ago


Brockville, Canada Trillium Health Care Products Full time

**PRIMARY RESPONSIBILITY**

Ensure all QC Documentation; Analytical Work Cards, Forms, Standard Operating Procedures, Work Instructions and Analytical Work Card Packages are compliant with customer requirements, regulatory requirements, and industry standards.

**SPECIFIC DUTIES**
- Responsible for receipt and distribution of customer specifications through various portals and acting as primary contact for customer specification requests.
- Responsible for review of customer specifications, assessment of updates required, and issuance of document processes as needed.
- Work with QC leaders, analysts, and data reviewers to ensure that identified changes are processed through doc processes.
- Communicate with customers and provide support to customer requirements related to specification changes, including document change control updates as required.
- Update Raw Material, Finished Product and Packaging Component Specifications as required to remain compliant with regulatory requirements, USP/EP/NF/BP requirements, and internal Trillium documentation.
- Assist in the updating of documents associated with CAPA (corrective-action, preventative-action), 3-year reviews and change managements.
- Provide support to the Projects team with respect to creation of new raw material and packaging component analytical cards. Creation and review of 3-lot summaries and specification review.
- Participate in internal new product introduction meetings.
- Provide training and support with regards to Solabs document processes and change managements, including preparation of analytical documents, to QC team members.
- Provide back up support for projects with stability protocols and summaries.
- Provides support for projects with material summaries and reviews.
- Other duties as required by QC leadership.

**EDUCATION/EXPERIENCE**
- BSc in a related field required.
- Comprehensive knowledge of GLP, GMP, USP/NF/BP specifications and methods.
- Understanding and working knowledge of Quality system like change management and CAPA.
- Experience communicating with customers (internal and external). Excellent interpersonal, communication (written and verbal) and organizational skills are required.

**Job Types**: Full-time, Permanent

**Salary**: From $64,000.00 per year

**Benefits**:

- Company pension
- Dental care
- Employee assistance program
- Extended health care
- Life insurance
- Profit sharing

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday

Ability to commute/relocate:

- Brockville, ON K6V 5W5: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- communicating with customers (internal and external): 1 year (required)
- working with Quality systems change management and CAPA: 1 year (required)
- knowledge of GLP, GMP, USP/NF/BP methods: 1 year (preferred)

Work Location: One location



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