QC TECHNICIAN – Chemistry (NEW) 

SUMMARY DESCRIPTION OF THE POSITION

Attached to the supervisor, the tasks of the QC technician will be:

  • Take the samples provided for in the sampling plan for the water analyzes.
  • Sample raw materials, packaging components and other materials.
  • Perform visual inspections.
  • Perform physicochemical analyzes according to the established schedule, on the assigned samples (finished products, intermediate products, raw materials, packaging components, stability, validation) according to the specifications, methods, procedures and Good manufacturing practices (GMP) in place at Sterinova .
  • Verify QC laboratory instruments.
  • Purchase the material for analysis.
  • Respect the established procedures of sanitary rules, dress and hygiene required by the company and the GMP.
  • Maintain a readable and complete documentation of all test results, device readings and observations. Ensure the integrity and traceability of all generated and reported data and make the appropriate corrections according to Sterinova procedures and good documentary practices.
  • Perform any related tasks assigned by the Quality Control Supervisor.

 

Aptitude :

  • Experience in the pharmaceutical field and / or work in an analytical laboratory would be an asset.
  • Working knowledge of computers (Microsoft Word suite)
  • Ease of written and verbal communication.
  • Ability for team work.
  • Possess the sense of initiative; excellent concentration; aptitude for technical writing and analytical skills, good stress management.
  • Oral and written bilingualism (French and English) would be an asset.
  • Laboratory or a related field with two (2) years of experience.

This is a permanent, full-time position. To apply, please send your resume to Mrs. Michelle De Repentigny, Quality Control Director, by email at mrepentigny@sterinova.com or by clicking on the opposite button.

QC TECHNICIAN – Microbiology (NEW)

SUMMARY DESCRIPTION OF THE POSITION

Attached to the microbiology supervisor, the tasks of the QC technician will be:

  • Take the samples provided for the water analyzes and environmental sampling.
  • Perform visual inspections.
  • Perform microbiological analyzes
  • Manage the incubation samples and colony counts.
  • Work in classified rooms.
  • Purchase the material for analysis.
  • Respect the established procedures of sanitary rules, dress and hygiene required by the company and the Good Manufacturing Practices.
  • Maintain a readable and complete documentation of all test results, device readings and observations.
  • Ensure the integrity and traceability of all generated and reported data and make the appropriate corrections according to Sterinova procedures and good documentary practices.
  • Perform any related tasks assigned by the Quality Control Supervisor.

Aptitude :

  • Experience in the pharmaceutical field and / or work in a classified environment would be an asset.
  • Working knowledge of computers (Microsoft Word suite)
  • Ease of written and verbal communication.
  • Ability for team work.
  • Possess the sense of initiative; excellent concentration; aptitude for technical writing and analytical skills, good stress management.
  • Oral and written bilingualism (French and English) would be an asset.
  • Laboratory or a related field with two (2) years of experience.

This is a permanent, full-time position. To apply, please send your resume to Mrs. Michelle De Repentigny, Quality Control Director, by email at mrepentigny@sterinova.com or by clicking on the button opposite.

QC ANALYTICAL SPECIALIST

JOB DESCRIPTION

Attached to the supervisor, the duties of the QC Analytical Specialist will be to:

• Install and qualify analytical instruments (eg HPLC, UV-Vis spectrophotometer, FTIR, etc.)
• Write / revise Standard Operating Procedures for the use of analytical instruments.
• Write / revise protocols and reports for validation / qualifications of equipment
• Use and maintain equipment in operation according to specifications.
• Plan and organize the preventive maintenance program for analytical equipment in place that includes calibration of analytical equipment.
• Check / revise calibration certificates for analytical equipment received from external vendors.
• Check the equipment daily.
• Provide technical assistance when implementing new methods and / or instruments, transfers and problem solving.
• Train QC employees on new analytical methods / techniques.
• Perform chemical and physical assays on assigned samples according to Sterinova’s specifications, methods, procedures and GMP.
• Participate in the transfer of analytical methods.
• Participate in the drafting and execution of the validation / verification protocols.
• Check the changes in current pharmacopoeia (USP and EP) of our products and instruments.
• Perform any related tasks assigned by the Quality Control Supervisor.

SKILLS

• Knowledge of good manufacturing practices (GMP) and pharmacopoeia (USP, Ph. Eur. And BP) and their applications.
• In-depth knowledge of instrumental analysis techniques such as high performance liquid chromatography, infra-red spectrometry, ultraviolet spectrophotometry and gas chromatography. Any experience in other analytical techniques would be an asset.
• Working knowledge of computers and laboratory data acquisition and analysis systems. Knowledge of OpenLab software would be an asset.
• Ease of written and verbal communication.
• Ability for team work. Possess a sense of initiative, excellent concentration, aptitude for technical writing and analytical skills, good stress management.
• Oral and written bilingualism (French and English).
• Experience in the pharmaceutical industry.
• Bachelor’s degree in Chemistry or equivalent with a minimum of five (5) years of experience.

This is a permanent and full-time position. To apply, send your resume to Mrs. Michelle De Repentigny, Quality Control Director via email at mrepentigny@sterinova.com or by clicking on the opposite button.

QC ANALYST 

JOB DESCRIPTION

Attached (e) to the supervisor, the tasks of the QC Analyst will be to:

• Validate / verify chemical analytical methods necessary for analyzes of active pharmacological substances, finished products, raw materials and packaging components.
• Perform technology transfers.
• Perform chemical and physical analyzes according to the established schedule, on the samples (finished products, intermediate products, raw materials, packaging components, stability and validation) according to the specifications, methods, procedures and GMP in place at Sterinova.
• Maintain a readable and complete documentation of all test results, device readings and observations. Ensure the integrity and traceability of all generated and reported data and make the appropriate corrections according to Sterinova procedures and good documentary practices.
• Provide technical support on methods used.
• Perform any related tasks assigned by the Quality Control Supervisor.

SKILLS
• Knowledge of good manufacturing practices (GMP) and pharmacopoeia (USP, Ph. Eur. And BP) and their applications.
• Practical experience in classical chemistry and instrumental chemistry.
• In-depth knowledge of instrumental analysis techniques such as high performance liquid chromatography, infra-red spectrometry, ultraviolet spectrophotometry and gas chromatography. Any experience in other analytical techniques would be an asset.
• Working knowledge of computers and laboratory data acquisition and analysis systems. Knowledge of OpenLab software would be an asset.
• Experience in validation and writing of analytical methods.
• Ease of written and verbal communication.
• Ability for team work. Possess a sense of initiative, excellent concentration, aptitude for technical writing and analytical skills, good stress management.
• Oral and written bilingualism (French and English).
• Experience in the pharmaceutical industry.
• Bachelor’s degree in Chemistry or equivalent with a minimum of three (3) years of experience.

This is a permanent and full-time position. To apply, please send your resume to Mrs. Michelle De Repentigny, Quality Control Director at mrepentigny@sterinova.com or by clicking the opposite button.

PROCESS SPECIALIST

SUMMARY JOB DESCRIPTION

The Process Specialist, under the supervision of the Pharmaceutical Process Supervisor, is responsible for advising and participating in the process of selection and purchase of new equipment and process equipment, as well as for their implementation and testing.  He-she must also support the validation team in the qualification of new equipment. He-she is also responsible for the process transfer from a pilot scale to commercial scale.

TASKS RELATED TO THE POSITION

A) Technology transfer
– Participate in the optimization of the manufacturing process during the development phase
– Create / revise manufacturing sheets for engineering, pilot and commercial batches
– Participate in the optimization of the manufacturing process
– Be responsible for manufacturing engineering batches and pilot lots
– Improve and strengthen processes

B) Process optimization
– Select and commission equipment
– Evaluate the risk and reliability of equipment
– Train operators (process specific)
– Participate in the validation of products and processes
– Perform annual trend analysis on different processes

OTHER RELATED TASKS EXECUTED
– Give support to answer questions from several groups (R & D, QA, Production, Validation and Regulatory Affairs)

ACADEMIC TRAINING and EXPERIENCE

– Bachelor’s degree in Engineering or Science
– Minimum 2 to 5 years experience in the pharmaceutical industry
– Project management

Start of employment, as soon as possible. This is a permanent and full time position. For more information contact Jean-Philippe Gentès, President and CEO. To apply, click the button beside or send your résumé to info@sterinova.com

PACKAGING OPERATOR

JOB DESCRIPTION

Under the supervision of the production supervisor, the packaging operator has the responsibility to participate in all tasks related to the packaging of the product

Pack the manufactured product
Participate in filling the manufactured product
Perform assembly, adjustment and disassembly of packaging equipment
Sterilize the finished product (autoclave)
Perform manual and visual inspection of the finished product
Operate equipment for automated visual inspection
Label products
Clean parts and packaging equipment
Follow work instructions based on internal procedures
Complete equipment registers and packaging sheets
Prepare the packing rooms

OTHER RELATED TASKS

Assist at the warehouse (receiving or shipping material)
Assist in equipment maintenance
Assist in equipment validation
All other handling tasks

PREREQUISITES

DEC in pharmaceutical or DES with equivalent experience
Minimum of 5 years experience in pharmaceutical packaging
Good physical fitness (load shifting and repetition)
Autonomous, fast and meticulous

Position is available now. This is a permanent position, 40 hours / week. To apply, click the button opposite or send your résumé to info@sterinova.com

PRODUCTION OPERATOR

JOB DESCRIPTION

Under the supervision of the production supervisor, the production operator is responsible for participating in all tasks related to the production and filling of the product.

Weigh the raw materials
Formulation, filtration and filling of the solution of the manufactured product
Prepare the material for sterilization
Perform assembly, adjustment and disassembly of production equipment
Sterilize the finished product (autoclave)
Perform manual visual inspection of the finished product
Pack the manufactured product
Clean parts and production equipment
Follow work instructions based on internal procedures
Complete equipment registers and manufacturing & packaging sheets
Prepare the production rooms

OTHER RELATED TASKS

Assist in equipment maintenance
Assist in equipment validation
All other handling tasks

PREREQUISITES

DEC pharmaceutical or DES with equivalent experience
Minimum 5 years experience in sterile product manufacturing
Good experience working in clean rooms
Good physical fitness (load shifting and repetition)
Autonomous, fast and meticulous

This permanent position is available now. The schedule is 40 hours a week. To apply, click on the button opposite or send your résumé to info@sterinova.com

LABORATORY TECHNICIAN

Sterinova seek to fill a laboratory technician position for its Research and Development department. The position is to be filled as soon as possible. The schedule is Monday to Friday from 8 am to 4:30 pm, for a total of 40 hours per week. Here is the job description:

TASK DESCRIPTION

Under the supervision of the Product Development Manager, the technician is responsible for carrying out laboratory work on R & D studies, more specifically on R & D end product sample analysis and analytical method development. He-She ensures the integrity of all GLP analytical data and regulatory requirements appropriate to the R & D laboratory. Knowledge of the use of HPLC-UV, DAD and ELSD instruments is essential. Knowledge of the use of GC-MS and GC-FID instruments is an asset. Analyzing, documenting, interpreting the data and summarizing the results are the main tasks of the technician. He-She participates in the daily operations of the laboratory: formulation, maintenance, calibration, tests.

OTHER TASKS

  • Perform, chemical analysis and physical tests on R & D samples.
  • Maintain readable and complete records of all test results, instrument readings and observations.
  • Ensure the integrity and traceability of all generated data and make any necessary corrections in accordance with GLP requirements.
  • Immediately notify the supervisor of any discrepancies in trends or results of incomplete analyzes or other irregularities.
  • Provide technical support such as: the implementation of new methods and / or instrumentation, intra-laboratory transfer, formulation and provide assistance in investigations.
  • Participate in activities leading to product approval under the direction of a Senior Chemist / Senior Scientist (ie, Responses to a Letter of Impairment for Chemistry Problems, Investigations, etc.).
  • Prepare research and evaluation reports.
  • Participate in development studies or method validation (with the help of senior R & D staff), as needed.
  • Perform other related tasks.

REQUIREMENTS

  • DEC in Analytical Chemistry or BAC in Chemistry
  • Minimum 5 years of experience in R & D analysis laboratory.
  • Good knowledge of liquid and gas phase chromatography, spectrometry and other analytical techniques used in pharmaceutical development.
  • Experience in sterile product analysis and method development.
  • Good knowledge and application of pharmacopoeia (USP, EP, BP), GLP, and relevant guidelines from FDA and Health Canada.
  • Excellent written and verbal communication skills, ability to communicate and work effectively in a team environment.
  • Knowledge of applicable software (Microsoft Office, Openlab) and ability to solve chemistry-related problems (theoretical and instrument-related).
  • Good organizational skills. Multitasking capacity.
  • Bilingual (French & English). Fluency in English is essential.

To apply, send your resume to Mr. Jean Robichaud, Director, Product Development at jrobichaud@sterinova.com or hit the button beside.