Quality Associate

Quality Associate

Volt

Volt is immediately hiring for Quality Associate in Charlottetown, Prince Edward Island C1E 0A1 Canada.

As a Quality Associate, you will:

Responsibilities

• Supporting the incident programs (deviation, laboratory investigation, complaint, supplier etc), including reviewing, assessing the severity, and approving minor incidents and outcomes of Phase 1 OOS investigations and participating in the investigations of major incidents.

• Participating in the internal audit program and supporting external audit requirements.

• Managing and leading changes to SOPs and supporting changes to SOPs made by other departments through the change control review process.

• Supporting the APR Program, Metrics and Scorecards Reporting Program, including QSR.

• Monitoring and enforcement of GMP requirements during day-to-day operations for all departments within the company.

• Supporting the supplier management program.

• Inspecting and releasing rooms and performing facility inspections as part of general compliance activities.

• Preparing or assisting in the preparation of reports and protocols, including validation and qualification.

• Issuing, checking, and archiving QC notebooks.

• Providing GMP and SOP training to various departments.

• Managing product label masters and creation.

• Supporting the CAPA program.

• Supporting Analytical validation and process transfer activities, and the overall method and Analytical process lifecycle by reviewing and approving analytical validation data and revising, reviewing and approving protocols, reports and work instructions as needed.

• Participating in the Pest Control program, including inspection and investigation.

• Performing batch record review and data review for release of critical raw materials, active pharmaceutical ingredients, and final products.

• Releasing critical raw materials, active pharmaceutical ingredients, and final products after successful completion of Company batch release training.

• Supporting Process lifecycle by reviewing and approving creation and changes to batch records.

• Participating in document lifecycle activities of SOPs, and QA review and approval of SOP changes.

• This is a full time, contract opportunity.

The ideal candidate will have:

Required Skills & Qualifications:

• Strong knowledge of Good Manufacturing Practices (GMP) and Quality Management Systems (QMS) in a pharmaceutical, biopharmaceutical, or regulated manufacturing environment.

• Hands-on experience with Quality Systems, including Deviations, CAPA, Change Control, OOS Investigations, and Quality Incident Management.

• Experience performing batch record review, GMP data review, and product release activities for raw materials, APIs, and finished products.

• Experience with SOP management, document control, and regulatory compliance, including reviewing, approving, and maintaining quality documentation.

• Experience supporting internal/external audits, supplier quality management, and validation activities (analytical validation, qualification, and compliance inspections).

• Post-Secondary Education.

• Bachelor’s degree in a scientific field an asset.

• Three years of work experience with a food or drug manufacturing company.

• One-year direct experience in a Quality Unit position.

• Pay range: CAD$35 - $39.34 per hour.

• Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

• 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. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please indicate the specifics of the assistance needed.

• 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 consent to communications from Volt Information Sciences, Inc. and its identified recruiting partners regarding this job and future opportunities. You may revoke your consent at any time.