QA/qc Associate
4 days ago
Founded in 2012, Lancaster Technologies is located in the beautiful Niagara Region, our manufacturing facility in Fort Erie, Ontario is just minutes from the Canada-US border. We specialise in the manufacture of solid dose tablets, both in chewable and caplet form. We also provide packaging solutions, including high speed bottling, induction sealing & capping, labeling, cartoning and fulfillment.
In addition to manufacturing solutions, we provide add-on services to our clients, including the procurement of packaging and raw materials and logistic solutions.
If you’re excited with our company’s vision and want to start the path of becoming one of our future leaders, we’d like to hear from you.
**ROUTINE DUTIES**
- Test bulk tablets for all physical requirements as outlined in the specifications
- Perform bulk inspections on tablets
- Raw material and packaging material sampling and inspection
- Accurately document all tests/equipment used and all results obtained on release reports
- Work in accordance with approved methods, SOPs, GMP’s while performing tests and taking samples
- Perform QA review of executed batch records
- Perform internal calibration/metrology on lab and production equipment
- Maintain the equipment calibration/metrology schedule
- Record the temperature/humidity and differential pressures of specified areas of the plant and record in logbooks
- Maintain the retain samples as per SOP
- Perform sampling of domestic water as per SOP and send to lab for testing
- Perform Environmental Monitoring (EM) sampling as per SOP and send samples to lab for testing
- Prepare environmental monitoring reports
- Sample and test compressed air for oil vapor/dew-point/micro as per SOP
**QUALITY SYSTEMS DUTIES**
- Prepare, revise and maintain GMP standard operating procedures for management review/approval
- Compile data and prepare reports for client Annual Product Reviews (APR’s)
- Maintain finished product, raw material and packaging component specifications database
- Provide QA support in conducting investigations for complaints, deviations and defect reports
- Provide QA support in conducting process validation and equipment qualification studies
- Provide QA support in preparation for and during any regulatory and/or client audits
- Provide QA support in conducting self-inspections
- Ensure Quality policies and procedures are followed.
**Requirements**:
- Must be medically cleared to work in the plant and participate in medical surveillance program
- Bachelor of Science Degree in Chemistry, Biology, or related science considered an asset.
- Detail oriented, able to prioritize multiple tasks, work well under pressure.
- Strong interpersonal and communication skills (both oral and written), leadership, motivation, organizational qualities.
- Well-developed computer skills.
- cGMP knowledgeable considered an asset
- Experience with customer service, Health Canada and FDA audits considered an asset
- Shift work on occasion may be required.
'
Work Remotely
- No
Pay: $20.00-$25.00 per hour
Expected hours: 40 per week
**Benefits**:
- Casual dress
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Vision care
Flexible Language Requirement:
- French not required
Schedule:
- 8 hour shift
- Monday to Friday
**Education**:
- Bachelor's Degree (preferred)
Work Location: In person
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