Quality Specialist (Day Shift) Quality Specialist (Day Shift)

Nestle Operational Services Worldwide SA•Boca Raton, FL

About The Position

Under the direction of the Manager Quality Lab Services, the Specialist is responsible for performing routine and specialized non-routine laboratory procedures in a Quality Control (QC) laboratory. Duties are performed under limited supervision. Ability to take on a larger scope of support functions and increased responsibility for managing a range of projects.

Requirements

At least 6 years of experience in an analytical or microbiology laboratory. Experience in pharmaceutical or nutraceutical industry preferred. Evidence of high performance may be used to substitute required years of experience.
Subject matter expert in at least one specific instrument or analyte group. Has the proficiency and skill set to run several analytical instrumentation types: HPLC, UPLC, UPLC-MS, GC, GC-MS, ICP-OES, or ICP-MS. Experience with Empower software preferred. Or microbiology proficiency in USP or AOAC standard microbiology testing and screening methods, plus Gluten testing. Familiar with Environmental monitoring requirements.
Bachelor’s degree in chemistry, biology or another closely related natural science discipline preferred.

Responsibilities

Manages and performs root cause analyses and investigational studies for out-of-specification (OOS) and out-of-trend (OOT) results, including partnering with QC Analysts, Analytical Services, R&D, CTAG, Quality, and/or Operations to address problematic bulks and finished goods.
QC representative for material review board (MRB) meetings. Discuss non-conformance reports (NCRs) related to QC OOS investigations and responsible for executing any follow up actions required by QC.
Follow up on requests for additional or location samples for investigations (approximately 20 samples/month).
Print, report, and follow up on results reports daily for samples being sent to external laboratory: (approximately 3000 tests/month; 600 samples x 5 tests/sample).
Perform Gluten testing in-house for all samples submitted to the QC laboratory (approximately 350 samples per month).
Follow up on results for allergen testing: 10 samples for allergen test sent out / month
Interpret the microbial test results and countersign the Product Evaluation Forms with results: 600 PEFs per month.
Collect samples for Environmental monitoring (water samples, air samples and compressed air samples) for both facilities 901 and 1297 buildings (approximately 100 samples per month).
Create graphs and data to store the environmental monitoring results for audits (once per month). Interpret Environmental monitoring sample results (approximately 100 samples per month) (water and air samples) for the facility (two buildings 901 and 1297).
Provide support during audits (getting information and data ready as requested before and during the audit) as needed to provide data/results from microbiological perspective. (about 10 audits per year.
Records data, performs calculations, evaluates and reports results. Performs peer review of data and provides critical analysis of laboratory systems. Keeps management apprised of progress.
Prioritizes workload and meets scheduled timelines, including managing multiple priorities.
Follows and complies with all testing procedures, operating procedures, GMPs, and safety and health requirements, as applicable.
Demonstrates good housekeeping practices to minimize analytical mix ups, potential laboratory contamination and safety hazards. Understanding and handling of hazardous materials and waste using proper and safe techniques. Selected qualified associates, at the discretion of QC Management, will be responsible for handling hazardous waste management.
Trains and directs other analysts on laboratory practices, standard operating procedures, quality procedures, specific methods, and instrumentation.
Assists QC analysts with troubleshooting analytical instruments. Coordinates outside technical support as needed.
Coordinates and manages laboratory projects under Management guidance.
Reviews and approves product evaluation form (PEF) revisions.
Periodically performs duties of a higher position for the purpose of training and development.
Other responsibilities may be assigned as required based on business need or management decisions.