Building Your Career with QCL

QCL-Quality Compliance Laboratories provides contract analytical and consultancy services to it's clients. Equipped with state of the art equipment, dedicated staff and a strong commitment to our customers, you will find QCL a rewarding place to build your career. Our services, ranging from chemical separations to dissolution testing requires a diverse background of highly trained professionals in different disciplines. We invite you to submit your resume and join the team at QCL.

We have immediate openings for the following professionals:

• Working in a very fast paced environment by performing full analytical testing of assigned materials or products within standard times and under minimum guidance.
  The position relies heavily on comprehensive wet chemistry techniques, Dissolution, HPLC, GC, and AA testing on raw materials, in-process and final products per established SOP's and pharmacopoeial product specifications
• Documenting and reporting results in accordance with GMP and GLP
• Conducting laboratory investigation as required
• Providing technical support to other analysts
• Performing trouble-shooting on complex issues with respect to laboratory analysis and laboratory instrumentation
• Performing all work in accordance with all established regulatory, compliance and safety requirements
• Training junior analysts as required
• Maintaining professional relationship with Internal/External Customers

Skills & Qualification Required:

• University Degree in Science – preferably in Chemistry.
• Minimum of 2 years Quality Control experience in the Pharmaceutical industry in particular contract testing.
• Knowledge of GMP, GLP, Compendia, analytical techniques and method validation.
• Superior organizational and interpersonal skills.
• Ability to manage multiple projects and tasks concurrently and effectively
• Sound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, AA, TOC.
• Sound understanding of cGMP, ICH and FDA requirements.
• Excellent written and oral communication skills is a must
• Computer proficiency with MS Office programs.
• Ability to meet deadlines and prioritize tasks with strong attention to detail.

Quality Assurance Data Reviewer

Reports To: Manager of Quality Assurance
Location: Markham, Ontario

Primary Responsibilities:

The successful candidate will perform activities to assure compliance with applicable regulatory requirements by conducting audits, supporting training programs, and data/documentation review.

Responsibilities:

• Perform timely data review with a high focus on data quality to ensure accuracy, completeness, cGMP compliance, and neatness of analytical documentation
• Verify calculations and documented information such as reagent expiry, instrument calibration, logbook entries, control charts, etc. are present, complete and accurate.
• Issue and maintain client CoAs
• Issue and reconcile Quality Control laboratory workbooks and logbooks.
• Verify that all analysis performed were as per client’s methodology and/or compendial methods, and were in compliance with GLP and GMP requirements.
• Support training initiatives and ensure training records are complete and compliant.
• Review Standard Operating Procedures (SOPs).
• Archive and retrieve quality control data files.
• Audit and review data for accuracy, completeness and regulatory compliance.
• Assist in client audits and regulatory inspections as required.
• Review laboratory investigations conducted by Quality Control.
• Periodic review of training records, SOP’s, Change Control implementation, Deviation and OOS investigation.
• Assist in maintaining the Change Control system.
• Assist laboratory with regard to Out-of-Specification investigations, Exceptions and Corrective Actions.
• Other applicable tasks assigned by the QA manager

Education and Experience:

• University Degree in Science – Majoring in Chemistry
• Experienced in the review of raw material, finished product, stability and analytical method validation documentation.
• Minimum of 2-5 yrs quality experience in a regulated pharmaceutical environment, within QA, QC, and/or Regulatory Affairs disciplines.
• Thorough understanding of cGMP, ICH, Canadian, and FDA regulatory requirements.
• Sound knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, Dissolution, AA, TOC.
• Computer proficiency with MS Office programs.

General Skills:

The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Must be proficient at working in a team-based environment
• Must demonstrate good written and oral communication skills in English (competence in French is an advantage)
• Must have solid math skills
• Must be able to work with limited direct supervision
• Must have the ability to analyze data to extract pertinent information
• Must be attentive to detail
• Must have the flexibility to adapt to changing priorities.
• Must be able to manage multiple projects and tasks concurrently and effectively
• Must have good organizational and interpersonal skills.

Quality Control, and Research and Development Senior Scientist

Reports To: Laboratory Manager
Location: Markham, Ontario

The qualified candidate will develop and validate analytical methods for API and related compounds in drug products and drug substances/raw materials. Previous experience with experimental design, formulation development studies, forced degradation and stability studies is desired.

Candidates must be familiar with cGMP regulations, FDA, and ICH guidelines. They should have an excellent knowledge of chemistry, liquid and gas chromatography, dissolution and wet chemistry. Good understanding of USP and other compendia procedures and requirements is also necessary. Sound knowledge of laboratory instrumentation and experience in preparing SOP's, method development reports, validation protocols and validation reports are other important aspects of this job.

Requirements: This position requires a degree in Chemistry plus 5 years of pharmaceutical analysis experience with a strong knowledge of HPLC, GC, AA and other major pharmaceutical analytical instrumentation and related software.

Candidates must be able to plan and organize work with minimal supervision, interpret analytical data in regards to acceptability and consistency. Candidates must be computer literate in Word, Excel and Power Point.

Interpersonal skills, team playing and English fluency (written and spoken) are a must.

Manager/Director - Laboratory Operations

Reports To: Chief Scientific Officer

Principal Duties

• Managing activities of the testing laboratories (analytical and microbiological) for raw materials, components, in-process, bulk and finished products for release and stability testing in support of our client’s needs
• Ensure all testing, validation and development studies are carried out in accordance with cGMP and internal SOPs
• Ensure that all laboratory functions are performed in accordance with pertinent regulatory requirements
• Monitor and participate in client and regulatory audits
• Ensure that staff are suitably qualified and trained for required job functions
• Participate in scheduling of analytical work according to urgency
• Oversee supervisors and group leaders such that a strict adherence to a defined hierarchy is maintained
• Communicate goals effectively with staff and develop a team approach to achieving corporate objectives
• Evaluate the abilities and performance of subordinates, mentoring and setting appropriate individual goals to achieve greater overall departmental performance and worker satisfaction
• Manage and oversee investigations/corrective actions
• Communicate and work effectively with other departments ensuring that testing is performed accurately and in compliance with GLP, GMP, USP, BP, EP, SOP’s and/or other approved test methods, protocols and regulatory requirements
• Coordinate ongoing training of all QC laboratory personnel on SOP's, test methods, analytical equipment and proper laboratory techniques
• Develop, improve methodology and validate laboratory test methods
• Manage the stability program ensuring appropriate operation and documentation to support studies

The ideal candidate will possess;

• A minimum of B.Sc. with 10 years experience managing a pharmaceutical laboratory.
• A strong working knowledge of regulatory requirements 
• A thorough understanding of laboratory safety requirements, MSDS’s and WHMIS
• A thorough understanding of analytical chemistry and chemical instrumentation, including HPLC, GC, and other common pharmaceutical laboratory instrumentation.
• Experience with raw material, finished product, and in-process testing
• Ability to manage many diverse tasks and issues simultaneously through prioritization, delegation, and “hands-on” personal effort
• Self starter with effective interpersonal, leadership and organizational skills
• Fluency in English; both written and spoken

Supervisor - Laboratory Operations

Reports To: Lab. Manager / Chief Scientific Officer

Principal Duties

• Ensure all testing, validation, and development studies are carried out in accordance with cGMP and internal SOPs
• Train and develop junior chemists on various laboratory equipment and laboratory testing
• Participate in internal and client meetings to convey project progress and results from analytical studies
• Manage and oversee product testing and activities of laboratory personnel.
• Ensure testing is performed accurately and in compliance with GLP, GMP, USP, SOP and approved test methods
• Provides ongoing training to all QC laboratory employees in all relevant SOP's, test methods, analytical equipment and proper laboratory techniques
• Develop, improve and validate laboratory test methods
• Responsible for Operation as well as troubleshooting of HPLC, GC, and various other pharmaceutical laboratory instruments
• Responsible for scheduling and coordinating preventative maintenance and annual calibration of all Laboratory instrumentation
• Manage the stability program. Monitor and assure the appropriate operation and documentation supporting the stability program
• Responsible for monitoring and timely requisition of laboratory supplies

The ideal candidate will possess;

• a minimum of a B.Sc. with 5 years experience in the pharmaceutical laboratory.
• Strong working knowledge of cGMP and CFR requirements
• Thorough understanding of laboratory safety requirements and the MSDS system.
• Thorough understanding of analytical chemistry and chemical instrumentation, particularly HPLC, GC, and various other pharmaceutical laboratory instruments.
• Experienced with raw material testing
• Ability to manage many diverse tasks and issues simultaneously through prioritization, delegation, and “hands-on” personal effort
• Self starter with effective interpersonal, leadership and organizational skills.
• Fluency in written and spoken English
  

Please forward your resume to the attention of Human Resources at:

Thank you for considering QCL as your career choice.