WhiteCrow Research
QC Lab Sample Coordinator
WhiteCrow Research, Village at Chestnut Ridge, Delaware, United States
We are global talent research, insight, and sourcing specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our client’s in‑house talent acquisition teams.
About our client
Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over‑the‑counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.
The company partners with generic companies in US and Canada to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long‑term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value‑added manufacturing.
As a Director, Engineering Services, you will be responsible for…
Sample Management
Performing QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage.
Performing QC sample reconciliation and disposal.
Tracking inventory of product samples, stability samples, and test materials in the lab.
Using laboratory software for sample, reference standard, chromatographic column management.
Verifying accuracy of labeling/documentation provided with samples.
Informing QC Coordinator if chemical or reference standard is expired for removal from laboratory area.
Sending samples for outside testing. Submit samples to the appropriate labs for testing.
Creating and maintaining reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.
Compiling a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.
Using the purchasing system to procure laboratory supplies.
Providing status updates to QC management and other departments regarding the submission of samples.
Maintaining a safe work environment by following standards and procedures and complying with legal regulations.
Maintaining, operating equipment and instruments supporting sample processing.
Providing general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.
Working with internal resources to maintain lab in an optimal state. Cleaning lab working surfaces and disposing of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.
Under close supervision, learning to troubleshoot basic instrument problems.
Investigations
Escalating any trends/events to the QC Lab Manager.
Escalating any sample and reference standard documentation issues to the QC Lab Manager.
With guidance, participating in OOS/OOT/NOE and other investigations.
Assisting, as and when needed, scientists working in the laboratory.
Assisting in drafting, editing, and reviewing SOPs.
Training
Maintaining assigned training records current and in‑compliance.
Assisting in the training of laboratory staff.
Compliance
Performing assigned work in a timely and safe manner conforming to regulatory, company and compendia requirements within pharmaceutical manufacturing setting.
Documenting accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.
Following internal processes related to controlled substances.
Safety
Following EH&S procedures to ensure a safe work environment.
Following all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.
What you already have… Education & Experience
College graduate, preferably in a Science related field.
Laboratory experience related to sample management preferred.
Knowledge
Basic knowledge of sample management in a laboratory environment.
Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.
Competency in Microsoft Office Suite.
Proficiency with computer savvy.
Skills & Abilities
Ability to display and analyze data in a logical manner.
Good verbal and written communication skills as well as good computer skills.
Attention to details and accurate record keeping.
Establish and maintain cooperative working relationships with others.
Solid organizational skills
Ability to take initiative, set priorities and follow through on assignments.
Physical Requirements
Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.
Work is in an FDA and DEA‑regulated pharma lab environment with risk of exposure to various chemicals.
Must occasionally lift and/or move up to 15-25 lbs.
Ability to wear personal protective equipment, including respirators, gloves, etc.
Specific vision abilities are required by this job include close vision and color vision.
Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.
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About our client
Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over‑the‑counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.
The company partners with generic companies in US and Canada to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long‑term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value‑added manufacturing.
As a Director, Engineering Services, you will be responsible for…
Sample Management
Performing QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage.
Performing QC sample reconciliation and disposal.
Tracking inventory of product samples, stability samples, and test materials in the lab.
Using laboratory software for sample, reference standard, chromatographic column management.
Verifying accuracy of labeling/documentation provided with samples.
Informing QC Coordinator if chemical or reference standard is expired for removal from laboratory area.
Sending samples for outside testing. Submit samples to the appropriate labs for testing.
Creating and maintaining reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.
Compiling a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.
Using the purchasing system to procure laboratory supplies.
Providing status updates to QC management and other departments regarding the submission of samples.
Maintaining a safe work environment by following standards and procedures and complying with legal regulations.
Maintaining, operating equipment and instruments supporting sample processing.
Providing general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.
Working with internal resources to maintain lab in an optimal state. Cleaning lab working surfaces and disposing of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.
Under close supervision, learning to troubleshoot basic instrument problems.
Investigations
Escalating any trends/events to the QC Lab Manager.
Escalating any sample and reference standard documentation issues to the QC Lab Manager.
With guidance, participating in OOS/OOT/NOE and other investigations.
Assisting, as and when needed, scientists working in the laboratory.
Assisting in drafting, editing, and reviewing SOPs.
Training
Maintaining assigned training records current and in‑compliance.
Assisting in the training of laboratory staff.
Compliance
Performing assigned work in a timely and safe manner conforming to regulatory, company and compendia requirements within pharmaceutical manufacturing setting.
Documenting accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.
Following internal processes related to controlled substances.
Safety
Following EH&S procedures to ensure a safe work environment.
Following all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.
What you already have… Education & Experience
College graduate, preferably in a Science related field.
Laboratory experience related to sample management preferred.
Knowledge
Basic knowledge of sample management in a laboratory environment.
Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.
Competency in Microsoft Office Suite.
Proficiency with computer savvy.
Skills & Abilities
Ability to display and analyze data in a logical manner.
Good verbal and written communication skills as well as good computer skills.
Attention to details and accurate record keeping.
Establish and maintain cooperative working relationships with others.
Solid organizational skills
Ability to take initiative, set priorities and follow through on assignments.
Physical Requirements
Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.
Work is in an FDA and DEA‑regulated pharma lab environment with risk of exposure to various chemicals.
Must occasionally lift and/or move up to 15-25 lbs.
Ability to wear personal protective equipment, including respirators, gloves, etc.
Specific vision abilities are required by this job include close vision and color vision.
Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.
#J-18808-Ljbffr