QC Lab Sample Coordinator

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.

Responsibilities:

Sample Management

• Performs QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage.
• Performs QC sample reconciliation and disposal.
• Tracks inventory of product samples, stability samples, and test materials in the lab.
• Uses laboratory software for sample, reference standard, chromatographic column management.
• Verifies accuracy of labeling/documentation provided with samples.
• Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.
• Send samples for outside testing. Submit samples to the appropriate labs for testing.
• Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.
• Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.
• Uses the purchasing system to procure laboratory supplies.
• Provide status updates to QC management and other departments regarding the submission of samples.
• Maintain a safe work environment by following standards and procedures and complying with legal regulations.

Lab Equipment

• Maintains, operates equipment and instruments supporting sample processing.
• Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.
• Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.
• Under close supervision, learns to troubleshoot basic instrument problems.

Investigations 

• Escalates any trends/events to the QC Lab Manager.
• Escalates any sample and reference standard documentation issues to the QC Lab Manager.
• With guidance, participates in OOS/OOT/NOE and other investigations.
• Assists, as and when needed, scientists working in the laboratory.
• May assist in drafting, editing, and reviewing SOPs.

Training

• Maintains assigned training records current and in-compliance.
• May assist in the training of laboratory staff.

Compliance 

• Performs assigned work in a timely and safe manner conforming to regulatory, company and compendia requirements within pharmaceutical manufacturing setting.
• Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.
• Follows internal processes related to controlled substances.

Safety

• Follows EH&S procedures to ensure a safe work environment.
• Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.

Requirements:

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 visions 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.