Essential Functions and Responsibilities to ensure the quality and safety of the product will include, but
not be limited to:
- Prepare, revise and ensure that standard operating procedures (SOP) are being followed, and that laboratory information management systems (LIMS) and batch records are completed in detail, in total, and in a timely manner.
- May oversee the work of Chemists I and provide training or guidance.
- Successfully complete trainings and demonstrate working knowledge of topics such as Quality Assurance, Quality Control, safety, biosafety, and competencies in laboratory procedures.
- Perform analytical (physical/chemical) or microbiological testing and its procedures using laboratory equipment and/or microbiological procedures; keep documentation, testing records and logs.
- Develop and validate new methods as directed.
- Troubleshoot and resolve technical issues with methods, experiments and equipment.
- Prepare reports and documentation of findings.
- Aid in the training of technicians on laboratory operations and SOPs
- Clean and maintain the lab and equipment per protocols
- Data mining/research as needed/directed on samples and/or testing
- Verify and maintain organized, clean, sanitary, and safe conditions. Enforcement of safety and quality regulations
- Record all required data on appropriate forms or in appropriate systems.
- Responsible for ensuring all materials are tested appropriately, and meet INW quality standards.
- Ensure timely quality escalation of laboratory deviations, out of specification results, nonconformances and lab events.
- Adhere to all current Good Manufacturing Practices and Good Laboratory Practices
- Works closely integrating and operating in a team environment with minimal supervision.
- Perform duties safely and report unsafe conditions or actions
- Reporting to work regularly and timely is essential to the success of this position with the knowledge that there may be occasions where flexibility on hours is required.
- Assist the laboratory manager as needed and directed.
Must have experience running at least one of the following:
- GC‑MS Agilent 8890 with 7000D GC/TQ
- LC‑MS/MS Agilent 1260 Infinity II with a 6470 Triple Quad
- Waters UPLC with FTN and PDA detector
Minimum Qualifications:
- Bachelor’s degree in Chemistry, Biochemistry, or a closely associated field with laboratory course
work or Masters degree or PhD in same. - 4+ years’ of analytical laboratory experience (dietary supplement, nutraceutical, pharmaceutical, food industry or environmental is preferred). If MS or PhD then 2+ years of analytical laboratory instrumentation experience or microbiology Advanced experience and knowledge with analytical equipment and techniques such as HPLC/UPLC, HPTLC, LC/MS-MS, GC/MS-MS, FTIR, UV-Vis, ICPMS, Titration.
- Strong ethics and integrity; process driven.
- Mathematical skills—accuracy with arithmetic, subtraction, decimals, and percentages.
- Language skills—must be able to read, write, and comprehend instructions and hold general conversation in English.
- Computer Skills—must be familiar and proficient with Microsoft Office, and comfortable with/or learning databases, and other business-related software.
- Must be capable of working in a fast-paced GMP manufacturing environment and consistently meet due dates.
- Basic Lab- Normal dexterity for analytical chemistry lab work, pouring/ handling glassware, working with chemicals and processing data
Preferred Knowledge, Skills, and Abilities:
- Skilled in organization, superior communication, detailed documentation, ability to follow detailed instruction and standard operating procedures (SOP), and acute attention to detail; must be able to prioritize and to change priority dependent on situational urgency (as directed).
- Skilled in monitoring, analyzing, critical thinking and active listening.
- Demonstrate attention to detail, listening to understand, orientation to quality, problem sensitivity, problem solving, and ability to take initiative.
- Knowledge of food production processing, food/dietary supplement industry current Good Lab Practices, FDA, USP, AOAC, and lab ISO regulations, and basic computer data entry.
- Must be able to operate individually or as a team
Physical Demands: The physical demands described here are representative of those that must be met
by an employee to successfully perform the essential functions of this job.
- Must occasionally lift 25 lbs.
- Regularly required to sit, stand, walk, and potentially smell or taste.
- Specific sensing abilities required by this job include near vision, smell, taste and manual dexterity.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.