Quality Control, Quality Assurance & Microbiology

POSITIONS CURRENTLY AVAILABLE:

QC Documentation Reviewer

As a Documentation Reviewer in the QC Department, you have a B.Sc. or M.Sc. in chemistry and 5+ years’ experience in conducting testing or reviewing analytical chemistry data in the pharmaceutical industry.

You are logical and have excellent oral and written communication skills.  You have good familiarity with the documentation requirements for GMP production and GLP study support. You have great attention to detail in all work that you perform, and a quick mind for computations and trends. You are an expert at interpretation and evaluation of analytical data.

You will be required to understand and review data carried out using a wide variety of equipment including HPLCs with UV, DAD, ELSD and electrochemical detectors, GCs (including capillary column and headspace) with FID and TCD detectors, Karl-Fischer, UV-vis, FTIR, Osmometer, automatic titrators, pH meters, and wet chemistry analysis. 

You will be required to actively participate in various aspects of development and validation programs, including the writing or review of Method Development Reports, Stability Studies, Validation Protocols and Validation Reports.

Quality Assurance Associate

We are seeking a skilled Quality Assurance Associate with high energy level and initiative, You should have a B.Sc. or higher degree in Chemistry, Biochemistry or Microbiology, to 2-5 years Quality Assurance or Compliance experience in the pharmaceutical industry, excellent knowledge of the Canadian GMPs , US cGMP’s , FDA and ICH guidelines and strong verbal and written communication skills.

You will be responsible for maintaining and improving quality compliance, creating, reviewing and approving Standard Operating Procedures, reviewing and approving documents related to specification, analytical testing, production, such as batch records and associated testing data, validation protocols, calibration records, stability programs, deviations, OOS documentation, trending, and document control.

Director of Quality

At Dalton, our people are our greatest strength, and our success has been built on our technical capabilities and the way we manage our relationships with each other. Our culture is supportive and innovative, driven by some of the Industry's best and brightest people helping us make the impossible possible, compliantly. Are you at the point in your career where you are looking for an environment where you’re inspired to explore your passions, where your talents are nurtured and cultivated? Do you strive to innovate with leading-edge scientific technologies? If so, join our team of innovative drug developers working together to bring innovative, life changing discoveries to the global market. Dalton is a fast paced environment and has experienced tremendous growth in the recent years.

We are currently looking for an experienced Director of Quality to work in a pharmaceutical manufacturing environment to lead and manage the strategic and operational performance of the Quality, QC and Microbiology Departments, ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, while following to all regulatory compliance.

To qualify for this position, the candidate must possess the qualifications:

Duties would include, but not be limited to:

• Oversee operational activities in QA, QC and Microbiology areas to ensure timely completion of various of project tasks
• Establish and maintain Quality Systems and Procedures to ensure that the products and services are in compliance with cGMP requirements
• Host regulatory inspections and customer audits
• Prepare reports and other documentation required by regulatory agencies
• Establish, track and review quality performance indicators and trends
• Provide quality guidance and training
• Make a final decision about disposition of products

Education & Experience Requirements

• Minimum B.Sc. in a related science
• Strong leadership/team management skills.
• You must have excellent knowledge of the Canadian GMPs and FDA cGMP guidelines.
• 10+ years Quality Management (QA, QC, Microbiology) experience in the pharmaceutical industry
• Strong verbal and written communication skills
• Strong interpersonal skills

ANALYTICAL CHEMIST, LEVEL 1

We are seeking a skilled Analytical Chemist with a B.Sc. in chemistry and 2+ years’ experience using HPLC, GC, dissolution apparatus and automated titrators in the pharmaceutical industry.

You are careful in the laboratory have excellent oral and written communication skills. You have great accuracy and precision in all testing that you conduct.

Analytical Chemist, Research and Development

We are seeking a skilled Analytical Chemist, Research and Development with a M.Sc. or Ph.D. in Chemistry with 3+ years of experience with Method development and validation in Analytical R&D.

In this position you will be responsible for development and validation of analytical test methods for the product development. Key duties include design, development and validation of new analytical methods, protocols and reports write-up, draft specifications and other documents for regulatory submissions. Testing of R&D batches, raw materials and packaging components in accordance with GMP/GLP regulations may be required as needed. Work should be completed with little supervision/guidance in a timely manner.

To qualify for this position, the candidate must possess the qualifications:

• Complete all training assignments, SOPs and maintain personal training records
• Develop and validate new analytical methods with minimum supervision
• Execute and document all research work in accordance with current GMP/GLP regulations
• Maintain a clean laboratory environment and ensure that safety regulations are followed
• Interpret and compile analytical data, propose next steps on discussion with the Manager
• Prepare protocols, development and validation reports
• Participate in activities leading to product approval (i.e. deficiency letter responses for chemistry issues, investigations, etc., with specific tasks outlined by the Manager)
• Provide technical support and coaching to other R&D Analytical Chemists
• Participate in and/or lead for out-of-specs Investigations
• Complete Corrective and Preventative Actions (CAPA’s)
• Initiate and follow through with actions required to close Change Controls
• Research and prepare specifications for product and packaging material
• Attend project meetings and prepare project updates
• Participate in Internal, Customer and Regulatory Audits

Knowledge, Skills and Abilities:

• Superior theoretical and practical knowledge of organic, inorganic, physical and analytical chemistry including in-depth knowledge of gas and liquid chromatography, spectroscopy and other analytical techniques employed in the pharmaceutical development
• Familiarity with modern computer assisted analytical instrumentation methods as well as with older techniques (i.e. titration)
• Good understanding of GMPs and GLPs as well as with pertinent FDA and ICH guidelines
• Ability to communicate and operate effectively in a team environment
• Knowledge of applicable software
• Good organizational and Multi-tasking skills. Detail-oriented. 
• Excellent written and verbal communication skills.
• Problem solving skills with significant degree of judgment based on prior experience, scientific knowledge and literature search. Problems include routine and non-routine tasks, such as chemistry related issues (i.e. understanding the degradation pathway of the active), instrumentation related problems (understanding symptoms of HPLC problems and eliminating/repairing them) and first review of out-of-spec investigations.

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