Columbus Quality analyst ii Jobs – 4 Openings This Week

Quality Analyst II - 6 month contract
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Quality Analyst II - 6 month contract

Teva
Toronto, ON

Apply Now

Job details

Contract | Fixed term contract
2 days ago

Benefits

Employee stock purchase plan
Disability insurance
Dental care
Employee assistance program
Life insurance

Skills

Microsoft Word
Biochemistry
Microsoft Excel
Oracle
SAP
Laboratory experience
Laboratory information management systems
Quality management
Analysis skills
Quality assurance
Bachelor's
Packaging
Quality Control
Organizational skills
Pharmacy
Chemistry
Manufacturing
AI
Communication skills

Full job description

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact

Quality Assurance Associate II
Scarborough, Ontario
6 month contract

We are looking for a Quality Assurance Associate II to join our team. In this role, you will be responsible for reviewing and approving stability reports, conducting corporate standard gap assessments, evaluating and closing change controls, and reviewing and approving method transfer protocols and reports, as well as executed batch records. You will support new product launches and the release of imported products to the Canadian market, including assessing the impact of critical GMP-related issues. The role also involves reviewing supplier documentation related to product launches, product releases, validation activities, deviations, and change controls.

As a Quality Assurance Associate II, you will lead and support investigations related to deviations, Out-of-Specification (OOS), and Out-of-Trend (OOT) results, while ensuring compliance with regulatory and quality requirements. You will maintain establishment licenses for imported products and coordinate renewals as required. Additionally, you will investigate product complaints and ensure the timely review, closure, and approval of records within the Quality Management System (QMS), collaborating closely with both internal and external stakeholders to drive quality and compliance across operations.

How You’ll Spend Your Day

Provide quality oversight for activities related to imported products.
Review and approve GMP documentation for products supplied by Teva affiliates and third-party manufacturers, including release documentation, deviations, validations, and change controls.
Perform product release activities for Teva affiliate and third-party products destined for the Canadian market.
Collaborate with Teva affiliates and Local-to-Local (L2L) third-party suppliers to ensure GMP compliance, adherence to Quality Agreements, and timely resolution of quality issues.
Support the compliant and timely launch of products manufactured by Teva affiliates and third-party partners through effective coordination with internal and external stakeholders.
Investigate, review, and approve product complaints, ensuring timely closure of records within the Quality Management System (QMS).
Conduct thorough investigations of quality deviations and perform impact assessments related to Critical Incident Notifications and Alerts affecting imported products.
Monitor and report quality metrics and KPIs, including deviations, CAPAs, and batch release cycle times; prepare monthly and quarterly trend reports and drive timely completion of quality actions.
Draft, revise, negotiate, and maintain Quality Agreements with manufacturing sites, contract packagers, contract laboratories, and other external partners.
Perform executed batch record reviews for products supplied by Teva affiliates.
Prepare, review, and approve Annual Product Reviews (APRs) for imported and L2L manufactured or packaged products.
Support Vendor Master Data activities and ensure accuracy of quality-related information.
Maintain establishment licenses for imported products and coordinate renewals as required.
Review internal procedures and corporate standards, conduct gap assessments, and update SOPs to ensure ongoing compliance.
Oversee retain sample management activities, including receipt, storage, SAP updates, and destruction of expired samples in accordance with established procedures.
Support compliance initiatives, quality projects, regulatory inspections, and audit activities as required.
Lead and manage special projects involving cross-functional teams and Teva Global affiliates.
Perform other related duties as assigned.

Your Skills and Experience

Bachelor's degree in Chemistry, Biochemistry, Pharmacy, Microbiology, Life Sciences, or a related scientific discipline from a Canadian university, or an equivalent degree recognized by a Canadian university or accredited Canadian credentialing body.
3+ years of relevant experience in the pharmaceutical industry.
Experience in Quality Assurance, Quality Control, or other GMP-regulated environments.
Knowledge of USP, BP, and EP compendial methods and the ability to interpret and apply analytical testing methods.
Experience conducting analytical method evaluations and investigating Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
Strong understanding of Good Manufacturing Practices (GMP), current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
Working knowledge of quality systems including deviations, CAPAs, change controls, product complaints, and batch record review processes.
Proficiency with Oracle, LIMS, QMS, SAP, Microsoft Excel, and Microsoft Word.
Thorough understanding of pharmaceutical manufacturing, packaging, laboratory, and testing operations.
Strong analytical, investigation, problem-solving, and organizational skills.
Excellent written and verbal communication skills with the ability to collaborate effectively with internal and external stakeholders.

How We’ll Take Care of You

At Teva Canada we provide a rewarding and collaborative work experience, with career growth and development opportunities for employees, in a safe and caring environment! The typical hiring range for this position is $76,680-$94,600. The base pay offered may vary depending on job-related knowledge, skills, experience, education, and internal equity. In addition to base salary, this role may qualify for an annual bonus based on employment type. Certain positions may also be eligible for a sales commission structure as part of the overall compensation package. Beyond base pay, Teva also offers a comprehensive suite of wellness and benefits programs tailored to role and employment type, that continue to rank among the best in our industry! Our competitive offerings are designed to provide flexibility, security, and meaningful choices, empowering employees to thrive both personally and professionally throughout their journey with us.

As part of our commitment to well-being, employees may have access to:

Teva Canada’s choices Benefit Plan including Health, Dental, Disability, Life Insurance
Employee Assistance Program & Virtual Health Programs
Retirement Savings Programs
Employee Stock Purchase Plan (ESPP)
Time for yourself or those you care about, through paid time for Vacation, Wellness days, Care/Sick days, Teva Days and Volunteer Days
Education Assistance Program
Recognition programs such as Employee Service Awards
Employee Discounts
And much more!

More exciting details on the specific total rewards offerings to be provided at the offer stage depending on the position and employment type hiring for. This position will fill a current vacancy. Teva Canada may utilize AI- driven insights on skills and capabilities as part of our candidate recruitment process to align candidates with potentially suitable opportunities more effectively. Our recruiters and hiring managers remain the principal decision makers in the recruitment process.

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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Quality Analyst II - 6 month contract

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