An analytical, highly skilled, dedicated, and exceptional hardworking professional with over 10 years of Quality experience in the nutraceutical / dietary supplement industry (Microbiology field). Experience includes strong technical and regulatory awareness of USP, OSHA, HACCP, GMP’s and ISO standards for quality as well as, good communication, multi-disciplinary collaboration, organizational and problem-solving skills. Bilingual, knowledgeable in all Microsoft office programs, PLM, SAP (beginner), Lotus, AS-400 and search engines. Looking for a company where my experience and skills can be utilized contributing to the success and future progress of a company.
Overview
14
14
years of professional experience
Work History
Supervisor-Quality Laboratory Services
Nestle Health Science (former The Bountiful Company)
10.2017 - Current
Experienced with cGMP systems and the CFR, to address quality systems, production batch records and manufacturing requirements to maintain compliance with these guidelines
Interpret and communicate new or revised policies to laboratory team
Encourage creative thinking, problem solving and empowerment by acting as role model and mentor for the team
Provides coaching and monitoring of employee competencies and performance appraisals
Increased in-house testing by hiring new personnel and purchasing new equipment to support microbial analysis for additional sites within the NHS network
Ensures department metrics and cycle times are monitored and achieved
Microbiology representation and participation in cross functional site meetings
Ensure testing is performed accurately and in compliance with cGMP procedures, established regulatory requirements, SOPs, and other approved test methods
Perform Lab investigations as needed
Implement corrective actions as applicable
Oversees daily operation of Microbiology lab regarding routine testing of In-Process, Finished Goods and Raw Materials samples
Supports internal and regulatory audits
Collaborates in the creation, revision, training, and implementation of SOP’s and protocols
This includes QP’s, SOP, and other documentation revisions utilized at the NHS
Supports microbial Investigations Thru NCR creation and MRB meeting participation
Supervises environmental monitoring to ensure that the facility and equipment are functioning under a state of control, with sterile processes remaining within current FDA aseptic processing guidelines
Assists in the development and management of the Environmental Monitoring program for the facility, including but not limited to, SOP development and product and process flow planning to ensure all manufacturing processes are monitored accordingly
Oversees the work of professional staff by making and reviewing work assignments, establishing priorities, coordinating activities, and resolving related work problems
Document non-compliance and evaluate if further investigation is needed
Schedule / Track equipment calibration and maintenance records and assess for deviations.
Quality Control Lead Microbiologist
The Bountiful Company (former NBTY)
01.2015 - 01.2017
Oversees the work of professional staff by making and reviewing work assignments, establishing priorities, coordinating activities, and resolving related work problems keeping supervisor informed of lab workflow status
Perform daily raw data documentation results review & verification of specification limits
Perform routine testing of samples (raw materials, finished goods, etc.) according to established procedures
Conduct and/or coordinate completion of Environmental monitoring program and documentation
Collect Environmental Monitoring samples from other facilities, documenting and reporting results as necessary
Perform training of current and new employees
Perform sterility tests, aseptic technique qualifications, and media fill process validations
Verify accuracy of all instrument and equipment labeling
Perform isolation and identification of microorganisms
Document non-compliance data and evaluate if further investigation is needed
Verification of that all documentation for investigations and non-conforming products is completed in a timely manner
Submit samples to the appropriate labs for outside microbial testing
Track equipment calibration and maintenance records and assess for deviations
Enter test results or summaries into the specific report templates
Under the direction of supervisor, document results of deviation and investigations, causal analysis, corrective actions, and preventive actions, as well as writing non-compliance reports (NCR) Support Internal and external audits
Maintain quality records current for auditing purposes (equipment calibration and maintenance, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, etc.)
Place and received orders onto iBuy software, keeping track of supplies for proper laboratory functions.
Microbiologist II
Natures Bounty (NBTY)
01.2010 - 01.2015
Enhanced laboratory efficiency by streamlining sample processing and implementing new testing procedures.
Reduced contamination risk by maintaining a sterile laboratory environment and adhering to safety protocols.
Increased accuracy of test results through meticulous attention to detail during data analysis and interpretation.
Supported research projects with timely specimen collection, preparation, and documentation for various studies.
Education
Master of Science - Biology
Universidad Del Valle
Cali, Colombia
01.2000
Bachelor of Science - Biology
Universidad Del Valle
Cali, Colombia
01.1995
Skills
Staff Management
Data Analytics
Processes and Procedures
Delegation Skills
Training and Mentoring
Microsoft Office Experience
Goal-Oriented
Cross-functional Collaboration
Team Building
Task Prioritization
Problem Solving
Continuous Education
Leadership development & team building
Communication in the workplace
D&I workshop through company learning center system
Awards
Supervisory Employee of the Year, South Florida Manufacturing Society -2019
NBTY Associate of the Month for outstanding job performance – Quality Department NBTY March 2011
References
Upon request
Timeline
Supervisor-Quality Laboratory Services
Nestle Health Science (former The Bountiful Company)
Associate Clinical Project Manager at Nestle Health Science (Aimmune Therapeutics)Associate Clinical Project Manager at Nestle Health Science (Aimmune Therapeutics)