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Analyst I, QA Inspector

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.

 

ANALYST I, QA INSPECTOR

6 Month Term Position

 

Emergent BioSolutions is currently seeking an Analyst I, QA Inspector for our Quality Assurance Department. The successful candidate will have a high school diploma or equivalent and previous experience working in a regulated environment or in a packaging environment. Must have the ability to read, understand and follow standard operating procedures, protocols, work instructions, and other policies/procedures are required. Must have strong written and verbal communication skills, have the ability to work in a group environment and have strong accuracy and attention to details. 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 Analyst I, QA Inspector is responsible for verifying products and processes by providing over inspection and line clearances for our pharmaceutical packaging and inspection operations.

 

DUTIES & RESPONSIBILITIES

  • Conducts over inspection of all packaging operations (e.g., visual inspection, labeling, assembly/cartoning).
  • Lives our culture of “right the first time” and ensures quality and accuracy in day-to-day activities.
  • Executes and documents procedural steps in compliance with current Good Manufacturing Practices (cGMP) standards and other regulatory requirements.
  • Assists in line clearance activities.
  • Performs reconciliation activities through verification of product and label counts.
  • Assists in dispensing of product for various packaging operations.
  • Dispenses all labels to packaging operations.
  • Conducts sampling as per ANSI standards for attribute testing (ANSI Z1.4).
  • Supports the retained sample program.
  • Involved in the revision of SOPs and batch records related to various packaging processes.
  • Performs retained sample annual review for all retain product lots in inventory.
  • Supervision of workflow and product flow for WIP areas to the packaging operation.
  • Maintains label storage and control.
  • Handles disposition of all packaging defects and rejected materials.
  • Conducts random sampling and collection of finished product; inspects and prepares these samples for stability program, QC testing, and regulatory lot release submission.
  • Maintains records of packaging inspections for trend purposes.
  • Liaises with internal departments to ensure work schedules are on track.
  • Assists in QA review of packaging batch records.

 

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: 

  • High school diploma or equivalent is required; relevant post-secondary education in a related field is highly desirable.
  • Previous experience working in a regulated environment is an asset; experience in a packaging environment is ideal.
  • Ability to read, understand, and follow standard operating procedures, protocols, work instructions, and other policies/procedures is required.
  • Strong written and verbal communication skills.
  • Ability to work in a group environment.
  • Strong accuracy and attention to detail is a must.
  • Knowledge of pharmaceutical regulatory requirements is required.
  • Working knowledge of Microsoft Office Suite Products such as Excel, Word, and Outlook.
  • Ability to adapt to and complete shift work including days and nights.

 

ADDITIONAL REQUIREMENTS:

  • Citizenship/Permanent Resident or Valid Work Permit.
  • Successful completion of a Criminal Record Check.
  • Successful completion of a medical and eye examination will be 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.