Analyst II, QC Laboratory Services

3 weeks ago

Winnipeg, Manitoba, Canada Emergent BioSolutions Full time
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Analyst II, QC Laboratory Services (QCC) Evening Shift

Location:

Winnipeg, MB, CA, R3T 5Y3

Job Summary

Perform GMP compliant testing as required to support Raw Material testing, In-process, Finished Product Release & Stability, nonclinical / clinical studies, as well as assay or process validations.

Maintain laboratory documentation and perform preventative maintenance and calibration on laboratory equipment per established procedures.

Contribute to and author investigations, deviations, critical reagent and standard qualifications, validation/verification protocols and reports, supplier qualifications, CAPAs and change controls.

Train and provide assistance to junior staff; provide training to peers/junior staff in an effective manner.

Responsibilities

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

1. Receive test samples, standards, chemicals, and reagents; maintain accurate laboratory records and inventory for all laboratory materials.
2. Demonstrate proficiency when performing analytical test methods with minimal supervisory guidance.
3. Be proficient in a variety of analytical/biological/Compendia methodologies and techniques.
4. Report results and complete LIMS data entry in a timely manner. Perform peer review of QC data, review, and approval in LIMS.
5. Adhere to all effective STM's/SOPs and safety requirements and document laboratory work consistent with cGMP requirements.
6. Perform preventative maintenance / calibration on laboratory equipment and demonstrate proficiency in their use and maintenance in accordance with established procedures.
7. Execute critical reagent and standard qualification studies and write protocols/reports with supervisory or senior analyst guidance.
8. Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures.
9. Make detailed observations during performance of experimental tasks; obtain and interpret experimental data with supervisory guidance.
10. Contribute to and provide input for troubleshooting/laboratory investigation efforts. Perform investigative testing as assigned.
11. Write clear and concise assay forms, TMDs, and SOPs. Contribute to protocols, technical studies, and reports under supervisory or senior analyst guidance. Revise lab documentation including assay forms, test method documents, and standard operating procedures in accordance with document management procedures.
12. Provide training and assistance to peers and junior staff in an effective manner.
13. Execute development and validation studies and contribute to protocols/reports.
14. Identify opportunities for improvements within QC procedures and documentation.
15. Perform assigned tasks effectively with minimal supervision.
16. Must be available to work days, evenings or night shift based on business needs.

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

1. University degree or technical diploma in chemistry, biology, microbiology, or related field of study.
2. Minimum two to four years of directly related experience in a recognized professional or technical/scientific field. Experience in a pharmaceutical cGMP environment is an asset, but is not required.
3. Proficient in Microsoft Office - Word, Excel, PowerPoint.
4. Knowledge of pharmaceutical GMPs.
5. Knowledge of regulatory guidance.
6. Knowledge of laboratory techniques and safety precautions.
7. WHMIS and biohazard safety awareness.
8. Competent in laboratory safety and generally-accepted lab practice, including maintaining adequate written laboratory records.
9. Ability to work in a fast paced and highly regulated environment.
10. Able to multi-task and adapt to changing priorities.
11. Able to communicate and articulate information in both written and verbal forms.
12. Strong organizational and interpersonal skills; can work collaboratively with others.
13. Able to interpret analytical data to support research and development work.
14. Able to contribute ideas/solutions to aid in troubleshooting and investigations.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

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.

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

- Lead with Integrity

- We gain trust and confidence through ethics, quality, and compliance excellence

- Stand shoulder to shoulder no matter what

- We combine our best thinking and communicate openly to support each other.

- Own it always

- Every person at Emergent is engaged and accountable for delivering on our commitments.

- Break through thinking

- We take smart risks, pursue innovation and challenge ourselves to constantly improve.

- Compete where it counts

- We set the right goals and respect each other as we conquer them together.

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