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QA Specialist
2 weeks ago
Reporting to the Manager, Quality Operations, the QA Specialist will ensure all quality of manufactured products through to finished goods are properly evaluated, leading investigation of quality issues and non-conformances through proper Root-Cause Analysis and CAPA process. This position will be responsible for overseeing Quality assurance activities for both Warden and Ashtonbee sites.
He/she will evaluate and facilitate Change Controls, and perform data analysis using statistical techniques, master batch production records review, product audits and system inspection. Th QA Specialist will be responsible to build quality into the product and process; ensure quality system is maintained; GMP guidelines are implemented through training & regular inspection; records reviews; product/line audits, MFPS development.
**Key Accountabilities**:
- Act as a Quality lead in conducting root cause analysis for any customer complaints and internal quality issues. Lead a cross-functional team of SME’s in order to complete investigation on time. Recommends corrective and preventive measures and maintain records. Ensure root cause/preventive measures are identified and corrective actions are taken.
- Assist in evaluating Change Controls in the QMS and act a first line Quality assessor.
- Assists in preparing QA reports and Nonconformance CAPA status reports Assessment of product quality and conformance to specifications by reviewing batch production and testing / inspection records; review and evaluate quality-related data from inspection activities and analyze these data using statistical techniques
- Review reconciliation calculations for drug items as part of batch production record review prior to release of bulk and finished goods; may train & assist production in doing the calculations
- Complete QA Release documents; release products after review of documents and related test parameters; gathers all batch production documents and keeps as batch production packet; does overall review and completion
- Responsible for FG product releases and ensure that batch production records are complete, accurate and in compliance; Release products for shipment according to specifications; keep track of regulated drug products produced
- Provides information on latest standards, specifications, procedures and requirements related to existing and new products; works with Quality Engineering group in development of MFPS (Master Filling and Packing Specification) for new products. Coordinates the revision of MFPS when changes are required.
- Provides necessary specification documents and inspection forms to Production before filling and packing of any new products; may create, issue & review batch cards for drug & client-owned products
- Prepares Annual Drug Product Review reports and conducts mock retrievals
- Writes and reviews SOPs & WIs according to GMP & clients’ requirements, control QA documents and ensures all QA documents and references are current; updated and distributed accordingly.
- Enforces GMP compliance; good documentation practices and sanitation program; performs regular inspection/audits according to GMP requirements; reports GMP observations to QA Manager &/or Quality Compliance team
- May assist in writing validation protocols; execution of validation studies; and writing validation reports for drug products; gathering data and reporting using statistical techniques
- May assist in monitoring the calibration program of the site by maintaining calibration log and certificates
- May assist in any quality-related activities as required.
- Follow safety rules and regulations at all times.
**Skills, Experience and Education Required**:
- Postsecondary education in Science: Chemistry, Chemical Engineering, Biochemistry, or any related science, with Canadian University equivalency in Bachelor of Science. Preferably with a process engineering background and technical knowledge
- Minimum of 3 years’ experience in Quality Assurance and Compliance in a GMP environment such as pharmaceutical, food or cosmetics companies
- Previous experienced in electronic QMS involving deviation investigation and change control, documents review and control, product releases, conducting audits, handling customer issues, root-cause analysis (RCA/CAPA), troubleshooting, process validation
- Self-motivated and highly organized with the ability to work in a fast-paced environment
- Strong technical writing skills
- Process oriented person with GMP awareness
- Strong interpersonal and communication skills with the ability to handle customer complaints and to initiate necessary actions
**Job Types**: Full-time, Permanent
Additional pay:
- Bonus pay
- Overtime pay
**Benefits**:
- Casual dress
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Vision care
Schedule:
- 8 hour shift
- Monday to Friday
- Night shift
