Quality Control, Quality Assurance & Microbiology

POSITIONS CURRENTLY AVAILABLE:

Sample Coordinator/Clerk – QC Department – 1 Year Contract Position

We have an opportunity for a 1 year Contract position for a Sample Coordinator/Clerk in our QC Department.

A self-starter with high energy and initiative, you have some background in science, good attention to detail, have an aptitude for using Word and Excel and documentation experience, preferably in a pharmaceutical setting. You must also have superior organizational, interpersonal skills and strong verbal and written communication skills.

Primary Purpose and Scope of Position is to ensure control of test samples.  Log-in and tracking of samples is required. The Sample Coordinator/Clerk will also perform a variety of clerical duties for quality control staff, like collecting and compiling data from various samples, follow up on test status and interacting with subcontract labs to ensure work is done according to required timeline.

Duties will include:

• Log in samples
• Track sample status
• Collecting and compiling data from various samples
• Trending data, if required
• Sample reconciliation
• Correspondence with contract labs
• Preparing periodic reports
• Contact (email and phone) external contract test labs
• Arrange for shipment samples to contract test labs
• Monitor and restock standards, reagents, supplies and consumables
• Set-up and/or pull Stability samples, per protocol
• Prepare purchase orders for supplies, if required
• Following all safety policies and maintaining a clean and orderly work area
• Complete checklists for the lab, including safety and upkeep checklists
• Maintenance of documentation, including lab notebooks, equipment logbooks and analytical data, as required
• Report any issues  to supervisor immediately
• Other administrative duties relating to compliance and sample accountability

Requirements

• University degree or equivalent in Science.  Chemistry degree is preferred
• Minimum 1+ years’ experience in a laboratory setting and office experience preferably a pharmaceutical company.
• Excellent oral/written communication and interpersonal skills.
• Proficient with Word and Excel
• Must be willing and able to work in a structured work environment with regard to safety and consistent conformance to standard operating procedures and work place practices.
• Experience in basic analytical techniques.
• Demonstrated good documentation  skills
• Understanding MSDS and impact of correct storage conditions on the integrity of samples.
• Excellent at computer literacy such as Excel, Word
• Excellent reporting skills and ability to analyze and problem solve
• Understanding of GMP practice

Quality Investigation Specialist

We are seeking a highly experienced Quality Investigation Specialist who serves as the QA point-of-contact and/or QA lead for major non-conformance investigations. You should have a B.Sc. or in Chemistry or Microbiology, 5+ years Quality Assurance and Compliance experience in the pharmaceutical industry, excellent knowledge of the Canadian GMPs, US cGMP’s, Health Canada, FDA, and ICH guidelines, and strong verbal and written communication skills.

You possess extensive hand-on experience in leading and/or carrying out non-conformance investigations including risk assessment, root-cause analysis, and CAPA implementation. Your major responsibilities include authoring and/or critically reviewing investigation reports, perform internal trainings on investigation and CAPA, as well as interacting with regulatory agencies in audit settings.

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, 5+ years Quality Assurance and Compliance experience in the pharmaceutical industry, Sterility Assurance in a GMP environment, excellent knowledge of the Canadian GMPs, US cGMP’s, Health Canada, FDA, and ICH guidelines and strong verbal and written communication skills, experience interacting with regulatory agencies in an audit setting and correspondence is also required.

You will be responsible for improving and maintaining the GMP training program, participate in the self-inspection program, creating, reviewing and approving Standard Operating Procedures, reviewing and approving documents related to analytical testing, production, such as batch records and associated testing data, validation protocols, calibration records, stability programs, deviations, OOS documentation, trending, and document control.

Senior Analytical Chemist

As a Senior Analytical Chemist with a M.Sc. or Ph.D. in chemistry and 7+ years’ experience using HPLC and GC in the pharmaceutical industry, you are logical and have excellent oral and written communication skills.  You have great accuracy and precision in all testing that you conduct and interpretation of analytical data and technical report writing are your forté.

You will be required to conduct the following:

• Testing 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, oxygen headspace, Osmometer, automatic titrators, oxygen analyzers, pH meters
• Carry out wet chemistry analysis. 
• Participation in development and validation programs.
• Develop various methods for determination of different chemical entities and their properties, such as small molecules, peptides, proteins, DNAs and RNAs.

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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