Quality Control Analyst Full-time Job

Principal Duties and Responsibilities:

 

 

• Develop and validate methods within the QC lab for HPLC and other instrumental techniques with the goal of updating and improving existing methods.
• Develop and validate cleaning validation methods as required.
• IV Drug release testing for product comparison.
• Perform process validation and cleaning validation testing.
• Perform method transfer activities.
• Support new product introduction.
• Product, method and raw material trouble shooting.
• Participate on projects in the area of focus related to process improvement.
• Collaborate with other departments to proactively build quality into the processes and systems.
• Create and revise QC procedures as required.
• Provide support for internal and Regulatory Inspections.
• Identify and implement key process improvements to enhance systems, gain site efficiencies and elevate GMP requirements.
• Generate, gather and analyze data for reporting purposes.
• Complete all GMP Documentation correctly and in a timely manner.
• Complete all training assignments and maintain personal training records.
• Participate in and/or lead Non Conformance Investigations.
• Complete Corrective and Preventive Actions (CAPA’s).
• Initiate, and follow through with actions required to close Change Controls.
• Participate in Internal, Customer and Regulatory Audits.
• Other duties as assigned.

 

 

Knowledge, Skills and Abilities:

• Expert knowledge and understanding of analytical chemistry and instrumentation
• Proficiency with analytical instrumentation (pH meter, viscometer, Karl Fisher apparatus, UV, IR, HPLC, GC, UPLC)
• Knowledge of applicable software including LIMS, Empower and MS Office
• Sound knowledge and application of Health Canada and FDA regulations
• Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
• Excellent written communication and report writing skills
• Strong organizational skills and ability to multi-task; detail oriented
• Excellent problem solving and judgment
• Advanced ability in investigative techniques to troubleshoot analytical problems

 

 

 

Background and Experience:

 

 

• Bachelor’s Degree in Chemistry, or related discipline
• 3-5 years experience in the pharmaceutical industry in a Quality Control Laboratory.
• Knowledge of Pharmaceutical Manufacturing and Packaging an asset
• Demonstrated technical writing skills
• Well developed interpersonal and teamwork skills

 

 

 

Problem Solving:

 

 

• Recommends changes and requests investigations where required.
• Any deviations to procedures or systems are brought to the Management’s attention with logic, data and corrective measures

 

 

Working Conditions:

• Ability to work under stressful conditions and changing priorities
• Ability to support work in other shifts
• Numerous and varied responsibilities demanding attention and detail
• Working in general office and laboratory environments

Taro is a research-based international pharmaceutical company that was established on the principal that research and development would be the cornerstone of its growth strategy. Providing quality products through scientific innovations, diligence and precision is the goal of all of Taro's research programs.
Taro develops high-quality, proprietary and off-patent pharmaceuticals for markets in the US, Canada, Israel and other countries around the world. The Company produces a wide range of prescription and over-the counter products including tablets, capsules, suspensions, solutions, creams, and ointments.
Taro additionally synthesizes the active ingredients used in many of its key products. This vertical integration gives the Company a competitive advantage in availability of quality raw materials, reliability of supply and the cost of active pharmaceutical ingredients. This gives Taro control over the manufacturing and quality control process from the active ingredient through to the finished dosage form.