Specialist I, QA Operations

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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 .