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Specialist I, QA Operations

Location: 

Winnipeg, MB, CA, R3T 5Y3

 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

 

 

SPECIALIST I, QA OPERATIONS

 

Emergent BioSolutions is currently seeking a Specialist I, QA Operations for our Winnipeg site. The successful candidate will have a bachelor of science in a related discipline with a minimum of 5 years of experience or equivalent level of skills and experience. Must have advanced technical knowledge in a related scientific discipline, Quality Assurance, or Quality Systems. The ideal candidate will have a solid working knowledge of FDA, Health Canada, and EMA GXP regulations, and the interpretation and application of these regulations to the work environment. Excellent written and verbal communication, influencing, and negotiations skills are required to inspire trust and quickly build credibility within other departments at Emergent BioSolutions.  In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

 

THE COMPANY

 

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

 

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

 

THE OPPORTUNITY

 

The Specialist I, QA Operations serves as the technical expert in the QA Operations team, supporting lot release, floor compliance activities, providing support by managing deviations and corrective/preventative actions. Additionally, this position provides QA Operations support in quality systems, manufacturing, quality control, supplier quality management and product development activities. The specialist contributes to manufacturing safe products, in compliance with regulatory requirements at the Winnipeg site

 

DUTIES & RESPONSIBILITIES

 

This position is primarily responsible for:

  • Lot release
  • Quality oversight of Operational activities
  • Commercial and Clinical Product Distribution
  • Deviation and CAPA Management
  • Non-Conformances
  • Quality Systems reports and improvement projects for QA Operations
  • Compliance with GMP requirements, good documentation practices and adherence to Emergent’s procedures
  • CMO Quality Management

 

Duties and responsibilities include:

  • Lot Release
    • Monitor all incoming batch records and assign to QA Associates for review
    • Generate and maintain a schedule for batch record review
    • Provide support and oversight of the review process. This includes but is not limited to providing instruction in how a discrepancy should be addressed and ensuring that any deviations and/or discrepancies are dealt with in a timely manner.
    • For lots requiring regulatory release, ensure that the country lot allocation is consistent with the regulatory release being requested.
    • Partner with internal customers (Sales, Production Planning and Manufacturing, Contract Management) to provide continuous visibility to ongoing lot release
    • Compile and assess lot release metrics
    • Release of lots
  • Quality Oversight of Operational Activities
    • Ensure QA support/coverage is extended beyond core working hours
  • Commercial and Clinical Product Distribution
    • Monitor all incoming requests for shipments and assign to QA Associate for review
    • Provide ongoing communication with Sales of shipment status to avoid potential delays and to ensure review of shipments in order of priority.
    • Provide support and oversight of the QA Associate review process
    • Ensure that all requirements have been met for QA release of a product shipment. This includes but is not limited to review against applicable Quality Agreements and/or contracts associated with the shipment.
    • Aid in the review and QA approval of shipments
  • Deviation and CAPA Management
    • Deviation administration through consultation, review, assessment and participation in deviation investigations
    • Ensuring complete investigation including product impact assessment and root cause analysis
    • Ensures CAPA address the root causes of deviations and prevent future recurrence
    • Performing deviation investigations where appropriate
    • Preparation of deviation summaries
    • Deviation system reports
    • Review of Deviations and CAPA

 

  • Non-Conformances
    • Assign QA Associates for the review and assessment of non-conformances which includes but is not limited to OOS, LIR, UTIR, EMIR, SCAR, Lookbacks and Returned Product (RPN)
    • Provide support and oversight in the QA assessment/investigations
    • Aid in the review and QA approval of the non-conformances
    • Ensure timelines for completing the above assessments are met and/or appropriate action taken.
  • Quality Systems
    • Participate/support Quality System Improvement initiatives
    • Perform assessments or gap analyses of Quality Systems, as required
    • Prepare ad hoc, monthly, and quarterly quality systems reports/metrics, as required.
  • CMO Quality Management
    • Act as the QA representative contact point for the CMO
    • Review and approval of deviations, CAPAs, change controls and executed batch records for lot release
  • Act as QA representative on project teams or in meetings, and be able to represent QA at interdepartmental meetings
  • Aid in training of QA Associates

 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.


EDUCATION, EXPERIENCE & SKILLS: 

 

  • A Bachelor of Science in a related discipline with a minimum 5 years of experience or equivalent level of skills and experience.
  • Advanced technical knowledge in a related scientific discipline, Quality Assurance, or Quality Systems is a requirement. 
  • Broad and thorough technical and regulatory knowledge of current pharmaceutical analytical and manufacturing techniques / processes.
  • Solid working knowledge of FDA, Health Canada, and EMA GXP regulations, and the interpretation and application of these regulations to the work environment.
  • The ability to be detail and goal oriented, focused on teamwork and the customer, prioritize and adapt to business needs is required. 
  • Excellent written and verbal communication, influencing, and negotiation skills are required to inspire trust and quickly build credibility with other departments at Emergent.
  • Ability to work collaboratively as a team or independently.

 

ADDITIONAL REQUIREMENTS:

  • Citizenship/Permanent Resident or Valid Work Permit.
  • Successful Completion of a Criminal Record Check.
  • Medical assessment required upon hire.

 

Interested? Please visit www.emergentbiosolutions.com under the career section to apply today!

 

 

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.