Quality Chemist

** POSITION SUMMARY
** Carry out QC lab analysis of raw materials, in process samples, final products, and project samples so that results are accurately determined in a timely manner, properly communicated to customers, and performed in accordance with the established Quality Systems based on ISO 9001, FSSC 22000/ISO 22002, and all applicable cGXP. This ensures that the manufacturing operation is well supported, and outside customers are promptly served with the correct product, quality, and information.

As needed develop and validate analytical methods. Review data, processing records and or all other quality records for accuracy prior to release. Assist with Regulatory requests as it pertains to Quality Assurance.
** ESSENTIAL DUTIES AND RESPONSIBILITIES
** Key responsibilities include, but are not limited to the following:
* Carry out all work to the appropriate Quality Standards, ISO 9001, FSSC 22000/ISO 22002, cGXPs, and API, as appropriate in each laboratory.  Flag any issues as they arise.
* Responsible for daily calibrations of all lab equipment and maintenance of  records to the appropriate Quality Standards to ensure equipment is always ready for use.
* Work independently, as well as in a team, so that work is smoothly and efficiently handled, shift hand-over is completed with a full understanding of ongoing issues, support production operators in their in-process testing, with clear and current communication with the lab manager/supervisor of issues and how they are being handled.
* Recognize, investigate, and troubleshoot questionable results and equipment problems so that resolution of the matter is obtained in a timely manner, and the proper people are kept informed or asked for guidance.
* Analyze incoming raw materials, in process samples, finished goods, and project samples per the established SOPs using various instrumentation and techniques in the QC and API laboratories.
* Fully functional in API testing and API data review.
* Manages OOS investigations and ensures timely closure and resolution.  Responsible in ensuring any CAPAs implemented were effective and monitored.
* Drive the implementation of new testing methods and/or method improvments.
* Primary trainer in laboratory testing and tasks.
* Follows all Company policies, procedures, and instructions using cGMP so that work is properly and safely done, the quality system is maintained, and good housekeeping is carried out.
* Communicates fully with internal and external customers so that their requirements and results are fully understood, and any interpretation of the information is properly supplied.  Attend morning meetings with production to discuss testing status.
* Review and approve the daily logs reported by the QC lab.
* Provide technical and hands on leadership to resolve analytical issues, maintain all instruments, and help communicate data.  Ensure all instruments are functional and in good working order and meeting compliance requirements.
* Serve as a technical resource for customer complaints and requests.
* Input, update, and maintain specifications across the databases and systems and work with the Technical Team.
* Lead special projects through completion including, but not limited to, validation work.
* Oversee quarterly testing and data monitoring.
* Evaluate current instrumentation and their performance and make recommendations on potential new technologies and/or replacements.

Note:

The duties listed above are not all inclusive and may be subject to periodic updating or revision.
** The Ideal Candidate
**** Desired Background
** Bachelor’s degree in chemistry, or related field of study and a minimum of 5 years of lab experience.
** Knowledge, Skills & Talents
** More specifically, we would seek the following attributes and competencies for the position:
* Must be able to apply good safety practice, good laboratory practice - GLP, ISO 9001.
* Experience in cGMP, GDP and operate to the quality regime, i.e. FSSC 22000/ISO 22002 is strongly preferred.
* Has demonstrated experience and competence with all instrumental analysis and wet chemistry techniques such as GC, GC MS, HPLC, TLC, Liquid Chromatography, automated titrations, physical property testing, color measurement, and spectroscopic techniques; as well as be able to teach the techniques, demonstrate good lab practice, do basic troubleshooting, and maintain good records including lab books.  A good sense of smell is required for organoleptic testing.
* Computer skills are required as the chemists must be able to use databases, spreadsheets, word processing software, LIMS, and computer-controlled instruments.
* Must have excellent written and verbal communication skills.  Strong organizational skills, decision-making, and record keeping skills are also required.  The ability to work in a team environment as well as independently with minimal supervision is necessary with an aptness to provide adequate communication.  This individual will be customer facing and may be required to…