Quality Associate

Quality Associate

Description

• Volt takes great care of our great hires
• Volt is immediately hiring for Quality Associate in Charlottetown, Prince Edward Island C1E 0A1 Canada.
• As a Quality Associate, you will support Quality Assurance and Quality Systems activities within a regulated pharmaceutical manufacturing environment.

Responsibilities

• Support quality systems, including deviations, laboratory investigations, supplier quality events, complaints, OOS investigations, and CAPA activities.

• Review, assess, and approve minor quality incidents, Phase I OOS investigations, and assist with major investigations.

• Monitor and enforce GMP compliance across all departments.

• Participate in internal audits and support external audits, inspections, and regulatory requirements.

• Manage SOP revisions, document control activities, and change control reviews.

• Support Annual Product Reviews (APR), quality metrics, scorecards, and QSR reporting.

• Support supplier qualification, supplier management, and vendor compliance programs.

• Perform facility inspections, room releases, and general compliance monitoring activities.

• Prepare, review, and support qualification, validation, and compliance protocols and reports.

• Issue, review, maintain, and archive QC notebooks and quality documentation.

• Deliver GMP and SOP training to cross-functional teams.

• Manage product label creation, label master documentation, and label control processes.

• Review and approve analytical validation data, protocols, reports, work instructions, and process transfer documentation.

• Support analytical method validation, process transfer activities, and product lifecycle management.

• Participate in pest control inspections and related investigations.

• Perform batch record reviews and GMP data reviews for raw materials, APIs, and finished products.

• Release raw materials, APIs, and finished products following successful training and quality review.

• Review and approve new and revised batch records to support manufacturing and process changes.

• Participate in SOP lifecycle management and provide Quality Assurance review and approval of quality documents.

• Partner with Manufacturing, Quality Control, Regulatory Affairs, and Operations teams to ensure product quality, compliance, and continuous improvement.

• This is a full time, contract opportunity.

The ideal candidate will have:

Required Skills & Qualifications:

• Post-secondary education required.

• Bachelor's degree in a scientific discipline is considered an asset.

• Minimum 3 years of experience in a pharmaceutical, biopharmaceutical, food, or regulated manufacturing environment.

• At least 1 year of direct experience within a Quality Assurance or Quality Unit role.

• Strong knowledge of:

• Good Manufacturing Practices (GMP)

• Quality Management Systems (QMS)

• Regulatory compliance requirements

• Hands-on experience with:

• Deviations

• CAPA

• Change Control

• OOS Investigations

• Quality Incident Management

• Experience performing batch record reviews, GMP documentation reviews, and product release activities.

• Experience managing SOPs, document control, and quality documentation.

• Experience supporting audits, supplier quality management, validation activities, and compliance programs.

• Strong attention to detail, organization, and problem-solving skills.

• Excellent written and verbal communication skills.

• Pay Rate: 35.00 - 39.34 CAD per hour.

• Qualified candidates should APPLY NOW for immediate consideration.

• Benefits: Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

• Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact Volt.

• Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with applicable laws.

• By applying for this job, you acknowledge that you may receive communications from Volt Information Sciences, Inc. and its recruiting partners regarding this job and future opportunities.

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