Analyst Ii, Qc Laboratory Services

5 months ago

Winnipeg, Canada Emergent Biosolutions Full time

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 II, QC LAB SERVICES (CANADA)

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 II, QC Laboratory Services performs inspection and release testing of raw materials and packaging components as per USP/EP compendial test methods and standard test methods. The Analyst II, QC Laboratory Services performs testing as required to support method verification/validation and material & supplier qualification. In addition, he/she writes studies and reports to support investigations, supplier qualifications, and validation/verification studies. This position furthermore mentors junior staff.

DUTIES & RESPONSIBILITIES

Perform identification, assay and limit testing of raw materials and packaging components to support manufacturing requirements.
Well versed in a wide variety of analytical and compendial methodologies and techniques such as FTIR, pH measurement, refractometry, density/specific gravity measurement using density meter, UV-VIS, distillation, titrations, HPLC and GC.
Document laboratory work consistent with GxP requirements.
Maintain laboratory records and inventory for standards, reagents and laboratory supplies.
Perform preventative and corrective maintenance on laboratory equipment.
Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures.
Make detailed observations, consistently analyzing and interpreting data.
Work productively with other team members as well as on independent assignments; increased level of independence/productivity compared to Analyst I.
Write clear and concise SOPs; adhere to all effective SOPs and safety requirements.
Provide input on lab requirements and improvements.
Communicate professionally, verbally and in writing, with collaborators and external departments.
Train and provide assistance to junior staff.
Use experience and knowledge to investigate in order to identify the root cause of complex problems.
Execute development and validation studies and write protocols/reports; review and provide feedback.
Independently move projects forward.
Solve and clarify problems in collaboration with other departments.
Execute tasks with a focus on departmental objectives.
Guide project progression through appropriate decision making.
Maintain current understanding of regulatory requirements.
Perform tasks effectively with mínimal supervision.

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**:
University degree or technical diploma in chemistry, biology or related field of study.
Minimum of 2 - 4 years directly related experience in a recognized professional or technical/scientific field.
Experience in a pharmaceutical cGMP environment is an asset.
Proficient in Microsoft Office - Word, Excel, PowerPoint.
Comprehensive knowledge of pharmaceutical GLPs and GMPs.
Comprehensive knowledge of laboratory techniques and safety precautions.
WHMIS and chemical safety awareness.
Knowledge of regulatory guidance.
Ability to work in a fast-paced and highly regulated environment.
Able to multi-task and adapt to changing priorities.
Competent in laboratory safety and generally-accepted lab practice, including maintaining adequate written laboratory records.
Able to communicate and articulate information in both written and verbal forms.
Strong organizational and interpersonal skills and the ability to work collaboratively with others.
Able to interpret analytical data, reviewing a variety of identifiable factors.
Proficient in complex procedures and problem solving.
Able to provide training to peers in an effective manner.
Strong leadership skills, independence and initiative.

**ADDITIONAL REQUIREMENTS**:
Citizenship/Permanent Resident or Valid Work Permit.
Successful Completion of a Criminal Record Check.
Medical assessment req’d upon hire.

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