Quality Control Chemist

4 days ago

Hauppauge, United States Country Life LLC Full time

**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 shelf-life 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, in-process 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 in-process 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 15 - 35 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 all-inclusive list of responsibilities. Other acti

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