Reporting to the Quality Assurance Manager, the Quality Assurance Associate II is accountable for all activities relating to the review of manufacturing and related documents, which directly or indirectly impact batch quality in accordance with the requirements outlined in Standard Operating Procedures and Good Manufacturing Practices.

This position determines final disposition of materials, i.e. releasing or rejecting, and must ensure that all corporate and governmental regulations and procedures are upheld. The Quality Assurance Associate II may also be assigned to execute activities relating to data integrity assurance (e.g. audit trail reviews).

For internal candidates: Please note this is a Level 9B role.  The deadline to submit internal applications is 4:00pm on October 20.

Some or all of the following responsibilities may apply in accordance with SOP QAU.031 ‘Responsibilities of the Quality Unit’:

• Conducts batch record review and determination of batch status, e.g., release, reject, or product hold for further clarification or investigation
• Assess potential impact of incidents and processing deviations on the quality and suitability of the product for sale
• Reviews audit trails and other (electronic) data sources required to support batch record release
• Investigates individually, or as a team leader or team member, Product Complaints, Deviations, ECS, and Out of Specification results to determine product impact, root cause and corrective / preventive actions
• Provides oversight and QA approval to various systems (CAPA, DCR, DIR, CCR) through which quality history and trending are monitored and corrective/preventative actions or quality improvements are recommended, implemented and consistently managed
• Assists with or oversees complaint and Pharmacovigilance system as requested by management and ensures that all adverse events and complaints are investigated and reported in a timely manner as detailed in applicable SOPs and regulations
• Reviews, approves and monitors progress and closure of all Change Requests
• Reviews and approves GMP-related master documentation
• Participates in internal and external audit program as required
• Participates in inter-departmental meetings and teams to represent the quality department interests and subsequently serve as a communication conduit to collect/distribute related information
• If necessary, co-ordinates applicable activities of the quality department as appropriate
• Participates as an active member of validation activities, both in terms of protocol approval and in review/approval of data and reports
• Supports regulatory affairs activities as required in obtaining and preparing documentation needed for related filings
• Follows GMP and regulatory requirements while ensuring quality standards are met
• Observes and supports all safety guidelines and regulations
• Demonstrates the company mission, vision and values statements, policies, and current standard business practices
• Performs other related duties as required

Education

• Degree in a related science (e.g. Chemistry, Microbiology)

Experience

• Minimum 2 years of practical experience in a Quality function, or equivalent experience in a leadership role within Operations
• Practical experience obtained as part of a higher degree (e.g. Ph.D.) will be considered equivalent experience if the higher degree is in a related science
• Experience in a pharmaceutical manufacturing environment would be an asset (cGMP)
• Ability to work independently with minimal supervision
• Excellent verbal and written communication skills
• Strong problem solving and decision-making skills
• Detail-oriented