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QC Analyst

  Le Sueur, MN,  United States |  Full time

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Posting Date :  2022-09-06

Job Identification :  11081

Department  :  Quality Control

Role Summary: Reporting to the Quality Control Manager, this role is responsible for performing chemical analysis of raw materials, in-process, finished product and stability samples and ensures that testing results provide the highest quality support for manufacturing in compliance to cGMP, SOPs, and Bimeda quality standards.

Key Role Requirements:

  • Responsible for providing support to Production through the receipt, analysis, and review of raw materials, finished products, and stability samples while following cGMPs. 
  • Perform out-of-specification investigations and all required documentation per cGMPs and company procedures.
  • Support and contribute to Continuous Improvement Initiatives within the company.
  • Transfer analytical methods and assist with method validation
  • Executes test methods for pharmaceutical finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, dissolution, spectroscopy, and Karl Fischer
  • GMP Notebook documentation and data review
  • Mentoring junior staff members
  • Write and review Methods, Method Summary reports, and SOPs
  • May write, review, and approve test notes, analytical test reports.
  • May write and review laboratory investigations and CAPAs

 

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

 
 
 

Essential Requirements:

  • 3 years minimum of analytical chemistry experience
  • Practical experience with GMPs within a regulated environment
  • Bachelor’s degree in related science field
  • Working knowledge and troubleshooting of HPLC and GC
  • Excellent English verbal and written skills for liaising and communicating with internal departments
  • Strong problem identification and problem resolution skills
  • High level of proficiency with Microsoft Office
  • Highly motivated and self-directed, capable of multi-tasking, and able to work with minimal supervision
  • Results driven, demonstrating strong collaboration and decision-making skills
  • Extremely detail-oriented and analytical thinking with a strong work ethic and a positive team attitude.
  • Must have good interpersonal skills with the ability to work in a team environment and interact with others within the company

Desirable Requirements:

  • Experience in an FDA, Canadian Health, and or EU regulated Pharmaceutical manufacturing
  • Knowledge of USP methodologies
  • Knowledge and experience with Continuous Improvement program
  • Knowledge and troubleshooting of FTIR, UV/VIS, and dissolution apparatus

 

About Bimeda

 

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.

Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

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More Info at www.bimedacareers.com

 
 
 
 
 
 
 
 
 

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about Bimeda in Le Sueur

About Us

Bimeda is a leading global manufacturer,  marketer and distributor of animal health products and veterinary pharmaceuticals.  Through ongoing expansion and strategic acquisition,  Bimeda has established markets in more than seventy countries worldwide and has R&D,  manufacturing and distribution capabilities across Europe,  North America,  South America,  Africa,  Asia and Australasia.


global

OPERATES
IN OVER
80
countries

people

900+
EMPLOYEES

lab

9
R&D
and 7
REGULATORY LABS

factory

11
MANUFACTURING
facilities in
8 COUNTRIES

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