QC Analyst II (Weekends)

Job title: QC Analyst II

Location: Cambridge ON (In-office)

Position Type: Full-time regular

Shift: Day Shift Friday- Monday 7:00am - 5:30pm

Vacancy Status: This position is currently vacant

AI Disclosure in Hiring: We do not use artificial intelligence to screen assess or select applicants

Job Summary

Reporting to the Quality Control Project Lead the QC Analyst II is responsible for the analysis of raw materials in-process finished products and stability samples using various wet chemistry and instrumentation techniques to assure compliance to cGMP SOPs and Bimeda quality standards. This position also provides testing support for the Stability Program. Quality Control Analyst II is experienced with all types of laboratory equipment and can troubleshoot common instrumentation issues and provide guidance to junior QC Analysts.

Responsibilities include but are not limited to:

• Conducts all analytical (physical & chemical) testing of raw materials in-process samples finished products gases water and stability program samples. i.e. pH conductivity TOC viscosity potency and impurity tests.
  
• Reviews data results and documentation for QC analytical testing.
  
• Ensures that all work is carried out in compliance with company Safety policies Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
  
• Prepares samples for analysis according to company methods SOPs & applicable compendia (USP/EP).
  
• Performs specific analytical tests utilizing HPLC GC UV IR FTIR KF and other instruments.
  
• Documents analytical test results as they occur in logbooks and in-process test data in Production dockets as required.
  
• Analyzes data; keeping the supervisor informed of discrepancies deviations out of specifications (OOS) data and unusual trends as they occur.
  
• Assists with quality investigations as required.
  
• Ensures that reagents and supplies are replenished by informing QC Supervisor or preparing PO requisitions when required.
  
• Performs calibration of equipment troubleshooting issues and ensuring equipment is in good working order including arranging repairs when needed with outside vendors.
  
• Supports and provides training and guidance to junior analysts.
  
• Ensures that work areas are kept clean and tidy and cleans glassware after use when required.
  
• Provides independent oversight on the production floor verifying that manufacturing activities are performed in accordance with approved procedures specifications and regulatory expectations. This includes but is not limited to Line clearance activities In process and final QA checks AQL checks and Provide support and guidance for failure events.
• Other duties as assigned.
  
  

Requirements:

Essential:

• 3-5 years in a Pharmaceutical Analytical testing lab & supporting stability programs
  
• . in Chemistry Biochemistry or related discipline
  
• Analytical Wet Chemistry Lab experience using the following methods/equipment: titration pH Potency Conductivity Viscosity TOC UV IR GC HPLC assays
  

Compensation & Benefits

Competitive vacation policy effective upon hire.
13 paid holidays.
5 paid personal care days.
Medical dental vision STD & LTD benefits.
Defined Contribution Pension plan with employer matching 5%.
Employee Assistance Program.
Expected Salary Range: $55000 - $65000K / Year DOE

Core Behaviors Skills & Abilities:

THOROUGHNESS /DETAIL ORIENTED Ensuring that ones own and others work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.

INTEGRITY/PERSONAL CREDIBILITY Demonstrated ability and concern that one be perceived as responsible reliable and trustworthy.

ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation seek that information from various sources and then tackle a problem by using a logical systematic sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.

CHANGE AGILITY/ADAPTABILITY The ability to demonstrate support for innovation and for organizational changes needed to improve the organizations effectiveness; initiating sponsoring and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose and embraces change. Strives for continuous improvement.

FOSTERING COLLABORATION / TEAMWORK - is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team as a team leader the ability to demonstrate interest skill and success in getting groups to learn to work together. Builds partnerships for global performance. Respect other.

About Bimeda

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

Bimedas 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.

Bimedas 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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Required Experience:

Manager