QA and Validation Specialist (Cambridge)

QA and Validation Specialist (Cambridge)

22 Oct
|
Avaria Health u0026 Beauty
|
Cambridge

22 Oct

Avaria Health u0026 Beauty

Cambridge

About Avaria Health and Beaty Corp.

Avaria Health and Beauty Corp. is a established manufacturer in the health and beauty industry, founded in 1995 and headquartered in Cambridge, Ontario . The company specializes in developing and producing a wide range of products, including topical creams, oils, lotions, and over-the-counter (OTC) medications for both retail and private label markets. As part of a recent company-wide initiative to reinforce our commitment to excellence, we are currently strengthening our quality assurance and manufacturing processes.

This creates a dynamic workplace where meticulous attention to procedures and compliance is highly valued, offering a unique opportunity for professionals to contribute significantly to our core operations during this important phase.

Education and Experience Requirements

- Minimum Education: Bachelor’s degree in chemistry, biology, life sciences, pharmaceutical sciences, or chemical/biochemical engineering, or equivalent
- Minimum Experience: 2–3 years of experience in a GMP-regulated industry (OTC drugs, NHP, pharmaceuticals, cosmetics) in at least two of the following areas: QC laboratory testing; QA (batch record review, deviations, CAPA, document control); validation and qualification (IQ/OQ/PQ, cleaning, protocol execution)
- Working knowledge of 21 CFR Part 211, 21 CFR Part 11 and data integrity principles (ALCOA+)
- Note: Hands-on experience with analytical laboratory instrumentation and with validation protocol execution is considered an asset; education may be substituted with relevant technical experience

Job Purpose: The QA/Validation Specialist is a bridge role between Quality Assurance and Validation, performing QC, QA and validation activities in support of the Senior Quality Specialist and the Validation Specialist at Avaria Health & Beauty Corp. The role supports the execution and maintenance of the Quality Management System, including investigations, CAPA, interim controls and effectiveness checks.





The QA/Validation Specialist works under the direct supervision of the Senior Quality Specialist and the R&D; Scientist and Scientific Affairs Officer; validation tasks are prioritized jointly with the Validation Specialist.

Key Responsibilities:

- Perform raw material, packaging, in-process, finished product and stability testing per approved methods and sampling plans, recording all raw data (balance readings, lot numbers, calculations) in the laboratory logbook and the Lab Testing Log
- Act as analyst or second-person verifier of laboratory results: check transcribed results, lot numbers and calculations against raw data, and review complete instrument sequences (all injections, integrations and system suitability) against the electronic files before results are reported
- Receive and log samples with chain of custody; prepare contract laboratory submissions with the applicable specification and method status; perform first review of contract laboratory reports against specification and route them to the Senior Quality Specialist for sign-off
- Maintain the inventory of reference standards, reagents and solutions; perform the monthly expiry check and remove and document disposal of expired items
- Perform routine monitoring (conductivity, microbial counts, etc.); download and review stability chamber and warehouse temperature/humidity data loggers (raise deviations of excursions and prepare monthly trends)
- Place batches on the stability program, perform pulls at the defined time points, maintain the stability chamber access log, and perform the annual visual examination of reserve samples
- Review bulk and finished product batch records (Avaria and contract manufacturer) and prepare the batch disposition checklist for Quality Unit approval
- Perform line clearance, component and lot code verification, fill weight and seal integrity checks, and second-person label checks where required
- Perform the bi-weekly check of the calibration and preventive maintenance schedule,



escalating any item within 7 days of its due date and tagging out overdue equipment; maintain the equipment census, status labels and calibration records, and compile data for the monthly calibration KPI
- Initiate and investigate QNCs, deviations, OOS results and complaints using root cause analysis tools, assess product impact, and propose CAPA with measurable effectiveness criteria
- Perform independent CAPA effectiveness verification for quality actions as required, using records generated after implementation, and document results in verification reports
- Draft and revise SOPs, forms and batch record templates; deliver training on new and revised procedures and maintain training records
- Support the Validation Specialist in drafting and executing validation and qualification protocols, including equipment IQ/OQ/PQ, process performance qualification batches, environmental monitoring and the deionized water sanitization effectiveness studies; record protocol deviations, compile data, perform statistical analysis and draft reports
- Perform interim cleaning verification (visual and swab/rinse sampling) of non-dedicated equipment, and support cleaning validation runs
- Support computerized system activities: execute ERP functional verification test, Part 11 and data integrity assessments, audit trail reviews and back-up/restore tests
- Support internal audits, contractor and supplier assessments (questionnaires and document review), Annual Product Review data compilation, continued process verification trending, and KPI data for management review
- Escalate quality concerns to the Senior Quality Specialist or the R&D; Scientist and Scientific Affairs Officer
- Maintain a safe working environment and report potential hazards.
- All other functions and duties as may be assigned by immediate supervisor.

Pay: $58,500.00 per year

Application question(s)

- Are you legally entitled to work in Canada for any employer without requiring a sponsorship?
- Are you able to work in an environment with exposure to various chemical raw materials and fragrances?

Work Location: In person

📌 QA and Validation Specialist (Cambridge)
🏢 Avaria Health u0026 Beauty
📍 Cambridge

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