Quality Assurance Associate Oshawa, ON Job ID 202635 Company Description A well-established production facility is looking to fulfill a key role within their organization, seeking a Quality Assurance Associate to join their team to help with the maintenance of regulatory establishment licenses.
Compensation A comprehensive compensation package is on offer, including salary, perks, and wellness program.
Position Description This role focuses on quality measures, ensuring adherence to necessary standards, and fostering ongoing enhancements in quality.
Review and validate all quality-related documents in accordance with regulatory standards.
Commence/Carry out quality necessities for all systems, compiling reports related to the receipt, management, storage, distribution, and product recalls.
Sustain and refresh all records, scrutinize all methods, and keep an eye on emerging regulations.
Create and uphold Standard Operating Procedures (SOPs) to certify compliance with GMP.
Assist in crafting and executing Corrective and Preventive Actions (CAPA) plans within stipulated timeframes.
Comprehend and finish manager-assigned tasks promptly.
Examine federal regulation as needed and contribute to the formulation of regulatory paperwork.
Qualifications Familiarity with GMP and GOP operational quality systems in commercial pharmaceutical and medical device supply chain operations.
Appropriate background in a pharmaceutical or related life science enterprise.
Proficient in handling quality system methods (Audit, Deviations, CAPA, Change Control).
Competent in formulating and executing SOPs and quality documentation.
Education Successful completion of a Graduate/Undergraduate degree in healthcare, pharmacy, or biotechnology is mandated.