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QA Laboratory Technician (Rutherford and Jane)
at Emily in York Region
Candidates must send resume to resume@gc-employment with the title "QA Laboratory Technician " and then register with us at http://www.gc-employment.com/jobsearch/index.php?option=com_catsuser&view=register
SUMMARY:
- The QA Lab Analyst reports to the QA Manager however will be working under the supervision of the QA Laboratory Lead Hand. You will perform analysis within the allotted time in accordance with approved methods, SOP's, cGMP & GLP requirements, on raw materials, semi-finished and finished products according to appropriate specifications. You will also conduct stability tests (real time analyses and accelerated stability studies) on new and marketed products. You will keep a record of all tests conducted and fully report their results.
- The QA Lab Analyst will apply experience and technical knowledge to investigate and evaluate process and procedural practices including deviations and recommend and adopt corrective action plans.
- The QA Lab Analyst will also conduct process audits in the manufacturing areas (Pre-Weigh and Batching) to ensure compliance with cGMP & company polices and procedures.
- The individual will also be responsible for reviewing analytical documentation of analysis, as well training of team members. The individual performs the testing; maintain records and laboratory samples in addition to assisting and supporting the laboratory staff as required.
RESPONSIBILITIES & DUTIES:
• Perform analytical testing of raw material, in-process & finished products.
• Maintain all related records within cGMP & GLP guidelines.
• Performs accurate documentation of tests performed & results obtained.
• Provide technical support in the completion of batches including troubleshooting of problems.
• Investigating & documenting out of specification results.
• Performs the development of the analytical test methods
• Perform process audits in the Batching and Pre-Weigh departments.
• Perform batch documentation reviews & assists in the investigation of non-conformances, product failures, customer/consumer complaints & quality incidents
• Provide experienced input with respect to development & amendment of procedures & practices in the analytical area.
• Recommend solutions to process improvements in the lab & manufacturing departments.
• Perform lab equipment calibration in accordance to procedures, record results & maintain calibration documentation.
• Assist QC Manager, QA Manager, R&D Director, QC Lab Lead Hand, laboratory personnel & other Company staff upon request
• Maintain an orderly filing system.
• Adhere to all QA/QC and Company policies and procedures including health and safety.
• Follow all procedures and wear personal protective equipment as outlined in the health and safety manual.
• Identify and report any hazard(s), accidents, injuries requiring first aid, health care, lost-time injuries, occupational diseases or incidents in the workplace.
• Any other related duties as required.
SAFETY:
• Incumbents will observe and comply with all company and government safety regulations and policies.
• Incumbents will report any unsafe act or condition immediately to their supervisor.
• Incumbents will immediately report any personal injury or accident that happens to them or others.
NOTE:
• This is not necessarily an exhaustive list of responsibilities, skills, duties and requirements associated with the position. While this list is intended to be an accurate reflection of the current position, Company reserves the right to revise the functions and duties of the job or to require that additional or different tasks be performed when circumstances change, i.e.: emergencies, changes in personnel or workloads.
• Company also expects incumbents to perform duties and responsibilities consistent with their skills and experiences should the need arise.
KEY WORKING RELATIONSHIPS:
Within the Company
• Incumbents will at all time act in a professional manner when dealing with customers and Company staff.
• Incumbents will report any abusive situations regardless of the origin of the abuse.
• As all staff of Company are representatives of the organization, their deportment on and off the job will reflect the professionalism of the organization.
LEADERSHIP:
Responsible for your own time and effort, only. May demonstrate work methods to new employees.
DECISION MAKING GUIDELINES:
Work is guided by detailed instructions in the performance of routine work. Refers all questions/problems to a higher authority or expert resource.
RESOURCES:
N/A
JOB SPECIFICATIONS:
Education & Experience
• Must hold a bachelor's degree in chemistry with a minimum of 3 years of experience.
• Good communication skills (written and verbal).
• Good knowledge of computers.
• Able to act in a professional manner with all internal and external business relationships.
• Must be able to work with minimal supervision in a"Team" oriented environment.
• Ability to work in a fast-paced environment and meet strict deadlines.
• Good inter-personnel skills.
• Knowledgeable in understanding and performing various product tests.
• Conversant with current Good Manufacturing Practices (camp) requirements
• Conversant with Good Laboratory Practices (GLP) requirements.
• Active participant in all Continuous Improvement (C.I.) activities.
WORKING CONDITIONS:
The job works in generally good conditions with occasional exposure [10% - 33%] to noise, odours, drafts, chemicals, operating machinery, temperature extremes, hazardous substances, etc.
SHIFT:
Fri: 11pm-7am
Sat: 7pm-7am
Sun: 7pm-7am
Mon: 11pm-7am
SUMMARY:
- The QA Lab Analyst reports to the QA Manager however will be working under the supervision of the QA Laboratory Lead Hand. You will perform analysis within the allotted time in accordance with approved methods, SOP's, cGMP & GLP requirements, on raw materials, semi-finished and finished products according to appropriate specifications. You will also conduct stability tests (real time analyses and accelerated stability studies) on new and marketed products. You will keep a record of all tests conducted and fully report their results.
- The QA Lab Analyst will apply experience and technical knowledge to investigate and evaluate process and procedural practices including deviations and recommend and adopt corrective action plans.
- The QA Lab Analyst will also conduct process audits in the manufacturing areas (Pre-Weigh and Batching) to ensure compliance with cGMP & company polices and procedures.
- The individual will also be responsible for reviewing analytical documentation of analysis, as well training of team members. The individual performs the testing; maintain records and laboratory samples in addition to assisting and supporting the laboratory staff as required.
RESPONSIBILITIES & DUTIES:
• Perform analytical testing of raw material, in-process & finished products.
• Maintain all related records within cGMP & GLP guidelines.
• Performs accurate documentation of tests performed & results obtained.
• Provide technical support in the completion of batches including troubleshooting of problems.
• Investigating & documenting out of specification results.
• Performs the development of the analytical test methods
• Perform process audits in the Batching and Pre-Weigh departments.
• Perform batch documentation reviews & assists in the investigation of non-conformances, product failures, customer/consumer complaints & quality incidents
• Provide experienced input with respect to development & amendment of procedures & practices in the analytical area.
• Recommend solutions to process improvements in the lab & manufacturing departments.
• Perform lab equipment calibration in accordance to procedures, record results & maintain calibration documentation.
• Assist QC Manager, QA Manager, R&D Director, QC Lab Lead Hand, laboratory personnel & other Company staff upon request
• Maintain an orderly filing system.
• Adhere to all QA/QC and Company policies and procedures including health and safety.
• Follow all procedures and wear personal protective equipment as outlined in the health and safety manual.
• Identify and report any hazard(s), accidents, injuries requiring first aid, health care, lost-time injuries, occupational diseases or incidents in the workplace.
• Any other related duties as required.
SAFETY:
• Incumbents will observe and comply with all company and government safety regulations and policies.
• Incumbents will report any unsafe act or condition immediately to their supervisor.
• Incumbents will immediately report any personal injury or accident that happens to them or others.
NOTE:
• This is not necessarily an exhaustive list of responsibilities, skills, duties and requirements associated with the position. While this list is intended to be an accurate reflection of the current position, Company reserves the right to revise the functions and duties of the job or to require that additional or different tasks be performed when circumstances change, i.e.: emergencies, changes in personnel or workloads.
• Company also expects incumbents to perform duties and responsibilities consistent with their skills and experiences should the need arise.
KEY WORKING RELATIONSHIPS:
Within the Company
• Incumbents will at all time act in a professional manner when dealing with customers and Company staff.
• Incumbents will report any abusive situations regardless of the origin of the abuse.
• As all staff of Company are representatives of the organization, their deportment on and off the job will reflect the professionalism of the organization.
LEADERSHIP:
Responsible for your own time and effort, only. May demonstrate work methods to new employees.
DECISION MAKING GUIDELINES:
Work is guided by detailed instructions in the performance of routine work. Refers all questions/problems to a higher authority or expert resource.
RESOURCES:
N/A
JOB SPECIFICATIONS:
Education & Experience
• Must hold a bachelor's degree in chemistry with a minimum of 3 years of experience.
• Good communication skills (written and verbal).
• Good knowledge of computers.
• Able to act in a professional manner with all internal and external business relationships.
• Must be able to work with minimal supervision in a"Team" oriented environment.
• Ability to work in a fast-paced environment and meet strict deadlines.
• Good inter-personnel skills.
• Knowledgeable in understanding and performing various product tests.
• Conversant with current Good Manufacturing Practices (camp) requirements
• Conversant with Good Laboratory Practices (GLP) requirements.
• Active participant in all Continuous Improvement (C.I.) activities.
WORKING CONDITIONS:
The job works in generally good conditions with occasional exposure [10% - 33%] to noise, odours, drafts, chemicals, operating machinery, temperature extremes, hazardous substances, etc.
SHIFT:
Fri: 11pm-7am
Sat: 7pm-7am
Sun: 7pm-7am
Mon: 11pm-7am
Published at 29-11-2011
Viewed: 76 times
Viewed: 76 times
