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QC Lab Technician 1

In New Jersey / United States

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QC Lab Technician 1   

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JOB TITLE:

QC Lab Technician 1

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Belvidere New Jersey / United States

JOB DESCRIPTION:

The Lab Technician working in the stability lab will timely analyze and / or test under cGMP and as per the Quality Department SOPs and Specifications, a variety of materials including API (Active Pharmaceutical Ingredients), raw materials, intermediates and finished products for Nutritional Supplements applying validated or compendia methods for the stability Testing for client Nutritional Products.
The Position
• Receives guidance and direction from the Technical Coordinator – Stability Lab or a designee/delegate.
• Performs/Applies Knowledge and skills to diverse and complex reactions.
• Raw Material Testing of products according to current compendia, regulatory, ICH guidelines and corporate quality systems.
• Ensures the samples are timely tested as per approved Quality Department SOPs and Raw Material, intermediate, Finished Product Specifications.
• Autonomous accomplishment of routine analysis in the laboratory.
• Prepares standards, mobile phases, and reagents.
• Maintains, monitors, and troubleshoots laboratory equipment (HPLC, GC, Auto-titrator, IR, etc.)
• Analyzes API, raw materials, intermediates, and finished products samples for required tests by various analytical and instrumental methods.
• Performs calculations, collects, and prepares data for evaluation.
• Reviews data for reporting and result entry into LIMS database.
• Orients and assists in training new colleagues.
• Reports results for batch specific stability studies, and route for management approval in a timely manner.
• Perform administrative lab tasks, such as the organization and archival of lab testing documents, and updating SOP’s.
• Keeps the Technical Coordinator (or a designee) informed of work status and suggests follow-up action to resolve atypical results and any problems encountered.
• Investigation of OOS
• Maintains Good documentation practices.
• Work closely and align with the Technical Coordinator on testing schedule.
• Ensure any testing issues or potential issues are appropriately and timely communicated to the Quality Control Manager.
• Ensure that all training is current and up to date.
• Recommend improvements and provide advice on routine operational procedures as related to testing.
• Author upon request relevant Quality Department SOP's under the guidance of the Technical Coordinator – Raw Material Lab.
SHE Duties & Responsibilities:
• Display and promote positive safety behaviors at all times; use proper personal protective equipment, appropriate safety tools, equipment and procedures to ensure that self and others go home safe each day; that area and equipment operate at the highest safety levels; that all people in the area (lab techs, quality personnel, maintenance, visitors, contractors, etc.) comply with the safety directives and keep the area neat and clean.
• Ensures incidents are investigated, reported, and risks are assessed in a timely basis.
• Acts in such a way that safety awareness & accident prevention are considered in performing all tasks
• Shows leadership by working to SHEQ standards and encouraging colleagues to work to the same standards.
• All employees to be aware of and follow all client Life Saving Rules.
• Support plant and corporate initiatives as outlined in the manufacturing plan.
• Reviews and ensures understanding of the SHEQ requirements, procedures, and instructions by the SHEQ culture on site.
• Completes analysis on stability samples for DNP products within an agreed upon turnaround time.
• Ensures SOP’s and shelf-life specifications are up to date and in alignment with approved Regional Stability Protocols during routine testing.
• Performs and documents all work associated in adherence with cGMP. guidelines.
• Safeguard the Stability Lab’s operation by ensuring ICH & US regulatory requirements are practiced.
• Ability to quickly respond to any testing not within specified limits.
The Ideal
• Bachelor’s degree in a relevant Scientific discipline required, Chemistry preferred.
• Broad / General knowledge of quality control techniques and methods.
• Broad understanding of safety, laboratory hygiene and GMP rules
• Good level of conceptual and analytical thinking.
• Good communication skills, verbal and non-verbal required.
• 0-3 years of experience in a lab of the Life Science Industry utilizing various instrumentation (HPLC, GC, IR, etc.)
• Experience working in a quality organization in a cGMP environment is desired.
• Experience in computer use (Microsoft Office: Outlook, Word, Excel, PowerPoint, SharePoint and internet) with ability to learn new computer applications including LIMS.
• Ability to comprehend and follow standard operating procedures and test methods
• Strong attention to detail and ability to multitask
• Operates with a sense of urgency in a fast-paced environment
• Strong organization, communication, leadership, and interpersonal skills
• Experience in GMP quality control and/or pharmaceutical and/or Nutritional Supplements manufacturing facility is preferred
• Pharmaceutical and/or Nutritional Supplements stability testing experience is preferred.

Position Details

POSTED:

Apr 20, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S1644638407855132

LOCATION:

New Jersey / United States

CITY:

Belvidere

Job Origin:

Jobsrus_organic_feed

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

QC Lab Technician 1    Apply

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The Lab Technician working in the stability lab will timely analyze and / or test under cGMP and as per the Quality Department SOPs and Specifications, a variety of materials including API (Active Pharmaceutical Ingredients), raw materials, intermediates and finished products for Nutritional Supplements applying validated or compendia methods for the stability Testing for client Nutritional Products.
The Position
• Receives guidance and direction from the Technical Coordinator – Stability Lab or a designee/delegate.
• Performs/Applies Knowledge and skills to diverse and complex reactions.
• Raw Material Testing of products according to current compendia, regulatory, ICH guidelines and corporate quality systems.
• Ensures the samples are timely tested as per approved Quality Department SOPs and Raw Material, intermediate, Finished Product Specifications.
• Autonomous accomplishment of routine analysis in the laboratory.
• Prepares standards, mobile phases, and reagents.
• Maintains, monitors, and troubleshoots laboratory equipment (HPLC, GC, Auto-titrator, IR, etc.)
• Analyzes API, raw materials, intermediates, and finished products samples for required tests by various analytical and instrumental methods.
• Performs calculations, collects, and prepares data for evaluation.
• Reviews data for reporting and result entry into LIMS database.
• Orients and assists in training new colleagues.
• Reports results for batch specific stability studies, and route for management approval in a timely manner.
• Perform administrative lab tasks, such as the organization and archival of lab testing documents, and updating SOP’s.
• Keeps the Technical Coordinator (or a designee) informed of work status and suggests follow-up action to resolve atypical results and any problems encountered.
• Investigation of OOS
• Maintains Good documentation practices.
• Work closely and align with the Technical Coordinator on testing schedule.
• Ensure any testing issues or potential issues are appropriately and timely communicated to the Quality Control Manager.
• Ensure that all training is current and up to date.
• Recommend improvements and provide advice on routine operational procedures as related to testing.
• Author upon request relevant Quality Department SOP's under the guidance of the Technical Coordinator – Raw Material Lab.
SHE Duties & Responsibilities:
• Display and promote positive safety behaviors at all times; use proper personal protective equipment, appropriate safety tools, equipment and procedures to ensure that self and others go home safe each day; that area and equipment operate at the highest safety levels; that all people in the area (lab techs, quality personnel, maintenance, visitors, contractors, etc.) comply with the safety directives and keep the area neat and clean.
• Ensures incidents are investigated, reported, and risks are assessed in a timely basis.
• Acts in such a way that safety awareness & accident prevention are considered in performing all tasks
• Shows leadership by working to SHEQ standards and encouraging colleagues to work to the same standards.
• All employees to be aware of and follow all client Life Saving Rules.
• Support plant and corporate initiatives as outlined in the manufacturing plan.
• Reviews and ensures understanding of the SHEQ requirements, procedures, and instructions by the SHEQ culture on site.
• Completes analysis on stability samples for DNP products within an agreed upon turnaround time.
• Ensures SOP’s and shelf-life specifications are up to date and in alignment with approved Regional Stability Protocols during routine testing.
• Performs and documents all work associated in adherence with cGMP. guidelines.
• Safeguard the Stability Lab’s operation by ensuring ICH & US regulatory requirements are practiced.
• Ability to quickly respond to any testing not within specified limits.
The Ideal
• Bachelor’s degree in a relevant Scientific discipline required, Chemistry preferred.
• Broad / General knowledge of quality control techniques and methods.
• Broad understanding of safety, laboratory hygiene and GMP rules
• Good level of conceptual and analytical thinking.
• Good communication skills, verbal and non-verbal required.
• 0-3 years of experience in a lab of the Life Science Industry utilizing various instrumentation (HPLC, GC, IR, etc.)
• Experience working in a quality organization in a cGMP environment is desired.
• Experience in computer use (Microsoft Office: Outlook, Word, Excel, PowerPoint, SharePoint and internet) with ability to learn new computer applications including LIMS.
• Ability to comprehend and follow standard operating procedures and test methods
• Strong attention to detail and ability to multitask
• Operates with a sense of urgency in a fast-paced environment
• Strong organization, communication, leadership, and interpersonal skills
• Experience in GMP quality control and/or pharmaceutical and/or Nutritional Supplements manufacturing facility is preferred
• Pharmaceutical and/or Nutritional Supplements stability testing experience is preferred.


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