SPECIALIST PLANT HYGIENIST

VIVOS HOLDINGS•Overland, MO

5d•Onsite

About The Position

The Plant Hygienist provides the leadership and technical expertise necessary to establish and maintain procedures for manufacturing hygienically safe and effective products. This position utilizes knowledge of microbiology, cGMP, manufacturing plant hygiene, machine design, and cleaning & sanitization practices to ensure that the environment, equipment, materials, and processes all are microbiologically acceptable. The Plant Hygienist provides leadership on the resolution of plant hygiene issues and on preventative measures and is responsible for benchmarking best practices for cleaning and sanitization across the manufacturing site.

Requirements

Bachelor’s degree in biology, chemistry or related field required, preferably with a strong Microbiology background. Applicable work experience will be considered in lieu of Science degree.
A minimum of 3 years in a QC/QA role in an OTC (over-the-counter) drug, cosmetic, medical device, or food manufacturing facility.
Laboratory experience (preferably Microbiology) is desired.
Knowledge of validation processes, particularly in regards to Cleaning/Sanitization Validations is desired.
Experience participating in customer, 3rd party, and FDA audits.
Knowledge of the FD&C Act and 21 CFR Parts 210/211 & 11 along with industry required standards for pharmaceutical and OTC drugs and ISO standards.
Superior communication and leadership skills required.
Project management, technical writing, data analysis, knowledge of Microbiology laboratory testing and practices, aseptic technique, and knowledge of current Good Manufacturing Practices are mandatory.
Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus.

Responsibilities

Dual role functioning in both the Validation and Microbiology Lab departments with a significant presence in the manufacturing plant environment.
Assist with Overall responsibility for ensuring that the QC Microbiology Lab has sufficient processes in place to meet all necessary regulatory and customer requirements, as well as meet all customer service needs.
Perform and document testing in accordance with SOP, cGMP and data integrity expectations. Microbiology Lab testing includes but is not limited to Finished Goods testing, Antimicrobial Effectiveness Testing, method suitability testing, raw material analysis, organism identifications, environmental monitoring, stock culture maintenance, cleaning/sanitization trials, etc as needed.
Communicate promptly and effectively with the Customer Service teams in regards to product release timing.
Assist in trouble-shooting any plant quality issues, specifically those related to possible microbiological contamination or cleaning/sanitization process deviations.
Assist with microbiological out-of-specification investigations of any non-conforming raw materials or finished goods including involvement in Corrective Action Preventative Actions and Process Variances Reports.
Effectively organize workload, analyze data, and report results to the proper departments.
Coordinate all equipment cleaning and sanitization validation projects, including protocol development and approval, scheduling and performance of validation trials, and preparation of final reports.
Assist with formal Change Control management. Monitor change controls for effects on the status of any currently validated cleaning/sanitization processes or the need for new protocol development.
Review & evaluate procedures regularly for their effectiveness in mitigating microbiological contamination risk. Revise as required for continual improvement.
Plan and coordinate periodic plant walkthroughs and implement improved practices based upon observations.
Work on special projects as assigned.
Function as back-up for other Microbiology and Validation team members, including Microbiology Manager.
Provide presentations to both the laboratory and other departments as needed.
Communicate with all levels of management to ensure quality issues are understood and preventive actions are taken.
Champion a positive quality culture to help ensure products in the market are pure, safe & effective along with meeting customer specifications.
Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts.
Presence for work when scheduled is mandatory. Work hours may extend past normal business hours based on the workload of the department.
Compliance to and enforcement of all company safety rules, procedures and guidelines is essential.