QA Specialist I

Gilead Sciences Canada, Inc.; Mississauga; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in Peel Region, Mississauga is seeking a Quality Assurance Associate to review production batch records and ensure compliance with Good Manufacturing Practices (GMPs). The ideal candidate will have 2+ years of experience in a GMP environment, strong communication skills, and a Bachelor's degree. This role offers the opportunity to work with cross-functional teams to maintain high-quality standards in drug production.

Qualifications

• 2+ years of relevant experience in a GMP environment.
• Prior experience in the pharmaceutical industry is beneficial.
• Ability to work in cross-functional teams.

Responsibilities

• Review production batch records and analytical data.
• Assist with investigations and CAPA recommendations.
• Maintain compliance with GMPs and GLPs.

Skills

Knowledge of GMP and GLP

Quality Systems knowledge

Investigational skills

Communication skills

Microsoft Office proficiency

Education

Bachelor's degree

Job description

Review executed production batch records, analytical data, and associated documentation, including any deviation and investigation reports related to lot release of Clinical Trial Materials, API’s and Commercial Drug Products in support of batch disposition with guidance from senior colleagues

Assist or coordinate with investigations, corrective and preventive action (CAPA) recommendations and change controls.

Interface directly with cross functional teams and infrequently with alliance partners to manage quality related issues.

Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).

Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.

May participate in the launch of new products for the Canadian market, with guidance from senior colleagues.

Assist in departmental planning activities to ensure that deliverables are provided according to project timelines.

Performs a variety of activities to ensure compliance with applicable regulatory requirements.

Normally receives general instruction on routine work, detailed instructions on new assignments.

Knowledge :

Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and / or Good Laboratory Practices (GLPs).

Good working knowledge of Quality Systems and cGMP standards applicable to clinical development.

Demonstrates basic knowledge of Health Canada and ICH regulations and standards.

Ability to effectively participate in cross-functional teams.

May assist with compliance audits as required

An accountable team player who is detail and quality oriented with solid understanding of QA principles, systems and procedures.

Demonstrates investigational skills such as root cause analysis

Demonstrates strong verbal, written, and interpersonal communication skills.

Demonstrates proficiency in Microsoft Office applications.

Specific Education & Experience Requirements :

2+ years of relevant experience in a GMP environment related field and a BS.

Prior experience in pharmaceutical industry is beneficial.

Gilead Core Values :

Integrity (doing what's right)

Teamwork (working together)

Accountability (taking personal responsibility)

For Current Gilead Employees and Contractors :

Please apply via the Internal Career Opportunities portal in Workday.

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