Quality Control Chemist - Hauppauge, United States - Country Life LLC

Description

Position Summary:

Testing vitamins and herbal products using HPLC, ICP, FTIR, NIR, HPTLC, UV-VIS and wet chemistry per USP, AOAC, FCC, BP (British Pharmacopeia) or other compendial sources.

Properly disposes of waste chemicals based on OSHA requirements.


Position Scope:
Handles approximately 3-5 samples per day for a minimum of 15-25 samples per week in addition with specific assigned projects


Position Responsibility:

• Works with lab instruments, e.g. HPLC, ICP-MS, ICP-OES, FTIR, NIR, UV-Vis to perform analytical tests. Chemicals and reagents will be used daily.
• Records the raw data and results from scientific test results.
• Reports any lab instruments malfunction to Lab Manager within 30 minutes.
• Prepares and files all Quality Control documents, e.g. Certificate of Analysis (COA) Deviations, Out of Specification (OOS) reports, change controls.
• Updates daily raw material, finished product and stability backlogs with updates on samples.
• Keep a daily log of tests performed that day and submit to QC Manager weekly.
• Perform daily and weekly cleaning of the lab, glassware, and desk area.
• Reviews testing and notebooks to prepare finished product and raw material release.
• Conducts daily calibration of balances, pH meter and moisture analyzer.
• Maintain master calibration schedule for all lab equipment.
• Maintain data logger temperature charts.
• Establish an expiration date for all product labels based on shelflife expectancy.
• Disposes of waste chemicals appropriately.
• Checks raw materials and finished product potencies.
• Maintains reference standard cabinet including biweekly review.
• Communicates with vendors for raw material or third party inquiries.
• Proper disposal of expired raw materials, inprocess and finished goods (final batches). Coordinates such activities with Safety Manager.
• Maintains full testing plan per item per year.
• Prepares samples for shipment to outside testing laboratory.
• Assists in the inventory of supplies and upkeep of laboratory and laboratory machinery.
• Preparation of purchase orders, receipt of supplies, and interfacing with other departments to expedite these functions.
• Prepares specification for raw materials and finished products. Conducts in process testing of manufactured samples.
• Perform testing on proposed new materials and work with other departments for approval and documents.
• Work on customer complaints and inquiries.

Chemist II:
in additional to the above

• Qualification and maintenance of primary and secondary standards of raw material and finished products.
• Maintains R&D raw material inventory, laboratory notebooks, equipment logs and maintenance schedules.
• Conducts minor repairs of lab instruments and other apparatus with guidance and approval from QC Manager
• Supports the preparation, manufacture, evaluation and documentation of new or modified R&D inprocess and finished products associated with Country Life formulations, e.g., tablets, capsules and powders.
• Writes detailed scientific instructions and lab procedures.
• Provides training for Lab tech and chemist I.
• Leads lab technicians.

Senior Chemist:
in additional to the above

• Develops analytical methods and validations.
• Analyses, records and releases raw materials and conducts maintenance of raw material and finished product specifications.
• Maintains lab chemicals for consistency to standards (e.g. USP, GLP and OSHA).
• Maintains customer complaint spreadsheet and inquiry responses
• Performs analytical troubleshooting and updates SOPs, log books and lab solutions preparation book.
• Leads and provides training for Lab technicians, Chemists I and II.

Micro:

• Testing pharmaceuticals, vitamins and herbal products for microbiological content/contamination according to USP, AOAC, FCC, BP (British Pharmacopeia) and internal procedures.
• Handles approximately analytical tests per week

General

• Must maintain clean working space, desk, equipment/glassware and whole lab.
• Must wear Personal Protective Equipment (PPE) at all times as stipulated by SOPs. e.g. respirator, ear plugs, hair net, beard cover, eye glasses and lab coat.
• Lifting up to 20 lbs. may be required. Position requires considerable standing on lab floor.
• Maintains professional and technical knowledge by attending educational symposia; reviewing professional publications; establishing personal networks; participating in professional societies, etc.
• Satisfactory completion of appropriate corporate training as related to the position and/or department.
• Assures compliance by following Food and Drug Administration's Good Manufacturing Practices (FDA cGMPs / GLPs) as well as other regulatory standards as required by the department.
• Contributes to overall achievement by accomplishing related tasks and demonstrating characteristics that exemplify team building and support.
• The above is not intended to be an allinclusive list of responsibilities. Other acti