QA Associate - On the Floor & Product Release - Day Shift, 12 month contract

Teva Pharmaceuticals; Whitchurch-Stouffville; On-site; CAD 70,000 - 88,000; Full time

Job summary

Teva Canada is seeking a Quality Assurance Associate for on-the-floor and product release support in Stouffville, Ontario. This 12-month contract involves auditing batch records, ensuring GMP/SOP compliance, and releasing bulk/finished goods with timely documentation.

You will collaborate with QA and operations to review deviations, CAPAs, and change controls, perform environmental monitoring sampling and data analysis, and support regulatory and cross-functional teams to meet release schedules.

Qualifications

• Hold a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.
• One (1) year of relevant Quality Assurance experience. Preferred: Three (3) years of relevant Quality Assurance experience.
• Must be computer literate with good working knowledge of TrackWise, Oracle and/or SAP ERP systems, LIMS and MS Office suite (Excel and Word).
• Good working knowledge of SOPs, GMPs applicable to Quality Operations, Quality Control, Manufacturing and Packaging. Understanding of Good Documentation Practices (including Data Integrity).
• This position requires a mechanical aptitude to understand manufacturing, packaging and quality control testing operations as well as the mechanical aspects of the plant.

Responsibilities

• Audit of executed manufacturing/packaging/testing batch records and release of bulk/finished goods in as close to real time as possible ensuring GMP and SOP compliance including electronic data review.
• Complete QA final identification sample, prepare accurate, clear and logical audit notices and maintain audit metrics.
• Provide quality oversight and support in the evaluation of quality floor incidents, which includes completing the Deviation Investigation Form (DIF), review and approval of Work Orders, review of PSS comments, review of change controls, electronic data review and performing trend analysis for walkthroughs and work orders.
• Lead and work collaboratively with site operations in the resolution of quality incidents and deviations by completing the DIF and determining product impact, root cause and applicable CAPAs to ensure compliance with GMPs and SOPs.
• Perform additional documentation audits/reviews and internal plant GMP audits such as logbook auditing, periodic trend analysis, BAS acknowledgement comments, Work Orders and evaluations.
• Perform sampling of water and environmental monitoring, annual sampling schedule preparation daily walkthroughs, review of log books, daily spot checks on the BAS, reviewing BAS acknowledgements and evaluating BAS incidents and periodic trend reports.
• Perform AQL evaluations including issuance, verification and evaluation and assist in the sampling and tagging of packaging material, bulk or finished products when required.
• Work collaboratively with site operations and QA in the resolution of GDP/GMP deviations to ensure compliance with GMP and SOPs.
• Respond to quality incidents as required.
• Support retention sample area if applicable.
• Liaise with Planning, Operations, Validation, Technical Operations, QC, Regulatory Affairs, Compliance and other QA teams to obtain necessary information/documentation required for product review/release to meet MPS schedule.
• Support in minor deviations, complaints, CAPA’s, CAPA ERs as and when required.
• Prepare a daily quality shift report and communicate with internal and external stakeholders on any queries related to batch release documentation.
• Other duties as assigned.

Skills

QA experience

GMP knowledge

Communication

Documentation

Project coordination

Education

Canadian university degree

Tools

TrackWise

Oracle

SAP

LIMS

MS Office

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 – On the Floor and Product Release

12 month contract

Stouffville, Ontario

Day shift : Tuesday to Saturday 6:00am-2:30pm

As a Quality Assurance Associate – On the Floor and Product Release, you will provide support to operations by performing quality review of executed manufacturing/packaging/testing batch records ensuring the correctness, accuracy and completeness of information and performing timely release of bulk / packaged finished goods including release to international market and private label customers. You will also provide quality oversight and support in the evaluation of quality floor incidents, which includes completing the Deviation Investigation Form (DIF), review and approval of Work Orders, review of change controls, electronic data review and performing trend analysis for walkthroughs and work orders. You will perform sampling of water and environmental monitoring, annual schedule, daily walkthroughs, review of log books, daily spot checks on the BAS, reviewing BAS acknowledgements and evaluating BAS incidents.

How You’ll Spend Your Day

• Audit of executed manufacturing/packaging/testing batch records and release of bulk/finished goods in as close to real time as possible ensuring GMP and SOP compliance including electronic data review.

• Complete QA final identification sample, prepare accurate, clear and logical audit notices and maintain audit metrics.

• Provide quality oversight and support in the evaluation of quality floor incidents, which includes completing the Deviation Investigation Form (DIF), review and approval of Work Orders, review and approval of PSS comments, review of change controls, electronic data review and performing trend analysis for walkthroughs and work orders.

• Lead and work collaboratively with site operations in the resolution of quality incidents and deviations by completing the DIF and determining product impact, root cause and applicable CAPAs to ensure compliance with GMPs and SOPs.

• Perform additional documentation audits/reviews and internal plant GMP audits such as logbook auditing, periodic trend analysis, BAS acknowledgement comments, Work Orders and evaluations.

• Perform sampling of water and environmental monitoring, annual sampling schedule preparation daily walkthroughs, review of log books, daily spot checks on the BAS, reviewing BAS acknowledgements and evaluating BAS incidents and periodic trend reports.

• Perform AQL evaluations including issuance, verification and evaluation and assist in the sampling and tagging of packaging material, bulk or finished products when required.

• Work collaboratively with site operations and QA in the resolution of GDP/GMP deviations to ensure compliance with GMP and SOPs.

• Respond to quality incidents as required.

• Support retention sample area if applicable.

• Liaise with Planning, Operations, Validation, Technical Operations, QC, Regulatory Affairs, Compliance and other QA teams to obtain necessary information/documentation required for product review/release to meet MPS schedule.

• Support in minor deviations, complaints, CAPA’s, CAPA ERs as and when required.

• Prepare a daily quality shift report and communicate with internal and external stakeholders on any queries related to batch release documentation.

• Other duties as assigned.

Your Skills and Experience

• Hold a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.

• One (1) year of relevant Quality Assurance experience. Preferred: Three (3) years of relevant Quality Assurance experience.

• Must be computer literate with good working knowledge of TrackWise, Oracle and/or SAP ERP systems, LIMS and MS Office suite (Excel and Word).

• Good working knowledge of SOPs, GMPs applicable to Quality Operations, Quality Control, Manufacturing and Packaging. Understanding of Good Documentation Practices (including Data Integrity).

• This position requires a mechanical aptitude to understand manufacturing, packaging and quality control testing operations as well as the mechanical aspects of the plant.

• Ability to clearly and logical explain ideas in a concise and organized manner with the use of proper grammar.

• High organizational skills used to set and manage priorities, handle multiple tasks in a timely manner, and ability to consistently evaluated work processes and outcomes.

• Must demonstrate ability to solve moderately complex problems and analyze and apply appropriate solutions.

• Ability to perform intermediate computations for quantitative data analysis.

• Be able to communicate effectively with cross-functional departments to resolve quality incidents or GMP infractions in a timely manner.

• Travel between sites (on an as needed basis)

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 $70,400-$88,000. 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 and Teva Canada may use an artificial intelligence (AI) system to assist with the initial screening and evaluation of job applications by analyzing for relevant skills, professional experience, and education, that best match the posted job qualifications. It is important to note that all final decisions in this process are made by a member of the hiring team.

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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.

EOE including disability/veteran