Qc Clerk

1 month ago


Brockville, Canada Trillium Health Care Products Inc. Full time

**PRIMARY RESPONSIBILITY**

Manages the chain of custody of Quality Control test samples from pick up, CALS log-in and distribution to the laboratories and QA. Reviews CoA’s for incoming raw materials. Maintains sample retains and provides support for laboratory supplies ordering.

**SPECIFIC DUTIES**
- Collect Finished Product samples from the production lines both morning and afternoon. Verify the number of samples provided against the Solabs packaging order. Verify all the strip label information for accuracy, separate samples by stage/department ex: Micro/analytical/approval/stability etc.
- Verify the product Rx number in JDE to confirm base formula, verify work order in JDE to confirm product name accuracy.
- Log samples to CALS. Generate associated data sheets for testing, place in corresponding work center bins for assignment.
- Place Finished Product samples in the same intake cage for analyst selection. Group Finished Products by product family.
- Verify incoming Bulk and In-Process samples against work order. Log to CALS and place in the Sample Intake Cage for analyst selection. Place datasheets in corresponding work enter bins for assignment.
- Ensure-In-Process samples and Tankers are taken directly to the Lab analyst for testing.
- Maintain sample cage and discard cabinets in alphabetical order, cycling out approved production on a weekly basis.
- Issue, receive, log and retain analyst logbooks as per retention process.
- Prepare discard lists for both Raw Material and Finished Product Retains as per MQA.SOP.009, obtain Director of Quality Services Approval and execute process. Maintain all discard list for a period of one year.
- Inventory and calculate all department Liquid and Solid Precursor Lab Waste, acting as departmental ARPC. Coordinate waste removal with Dispensing Group Lead (RPIC).
- Collect approved Finished Product Retain samples from the Quality Assurance Department. File approved FP Retains in corresponding Retain Storage areas (QC1, 2, or 3). Enter storage locations to the Finished Product Retain Database.
- Collect approved Raw Material Retains samples from the Sample Intake Cage. File approved sample in corresponding Retain Storage Area (QC#) based on the quarter they expire. Ensure Raw Materials with special storage conditions are maintained under required specification. Enter the sample information into the Raw Material Retain Database in Solabs.
- Perform CALS corrections and log activities into the Cals Data Change and/or Analytical Data Sheets Logbooks.
- Provide C or A and reference material for Assay as needed.
- Log to CALS compressed air results.
- Communicate incoming non-lims sample submissions and their required date to QC Supervisor-Projects for lab assignment to optimize flow.
- Maintain the record of analysis of Raw Material and Packaging materials. Facilitate and coordinate the exchange of lab records ex: RM and PKG.AWC, LIRS, for the purpose of off-site storage as per records retention requirements.
- Participate in Tours of Quality control Retain Storage areas and detail the CALS sample login process, flow of samples into the lab.
- Maintain Precursor Inventory, prepare yearly Health Canada Reports for in house precursor Raw Material Retains and Finished Product Retains.
- Function as departmental attendance taker, reporting directly to the Director of Health and Safety in the event of an emergency.
- Provide training ex, summer students
- Preform other clerical duties as required.

**EDUCATION**
- 2-year diploma in Science related field, and /or greater than 5 years’ experience in Pharmaceutical environment with proven knowledge of GMP documentation systems.

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

**Salary**: From $24.73 per hour

**Benefits**:

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

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday

Supplemental pay types:

- Overtime pay

Ability to commute/relocate:

- BROCKVILLE, ON: reliably commute or plan to relocate before starting work (required)

**Experience**:

- raw material and finished product: 2 years (required)
- proven knowledge of GMP documentation systems: 4 years (required)

Work Location: One location