GNC Stability Manager in Greenville, South Carolina
The Stability Manager is responsible for leading the Stability (shelf life) program at Nutra Mfg. The stability program includes Nutra finished products and select raw materials as well as 2nd Party (GNC Labeled products) and 3rd Party (Outside Customer products). The program must meet all FDA cGMP requirements for dietary supplements and applicable International requirements for foreign marketed products. The program will be optimized to leverage product family groupings of Nutra formulations. The program must identify formulations requiring modification and track changes to successful completion by working with the Product Development group. The position will lead Stability Scientists, Specialists, Coordinators, and Clerical support. The Stability Manager reports to the Sr. Director of Quality Control. This individual will have direct contact with 3rd Party Customers, Regulatory Agencies (Domestic & International), as well as serve as a strategic lead on stability discussions during 3rd Party and FDA GMP Audits. This individual will also be responsible for developing stability protocols and price quotes to support our 3rd Party customer business needs.
Essential Duties and Responsibilities
Administer the Nutra product stability program
Administer the Nutra raw material stability program
Administer the 2nd Party (GNC Label) Stability Services program
Administer the 3rd Party (Outside Customer) Stability Services program
Oversee the testing of products to affect the Domestic, International and third party testing schedule
Develop stability protocols designed to evaluate product chemical and physical integrity over time to substantiate expiration dating for the shelf-life of the product
Compile historical analytical results of selected products to set provisional shelf-life dates.
Maintain stability inventories to support the stability reporting requirements for all customers.
Interpret regulatory guidelines that govern the stability storage and testing of dietary supplements and medicinal for 50+ countries adhere to regulatory requirements such as cGMPs, PIC/s, and ICH.
Collect, manipulate, interpret and evaluate stability data and data trends using simple and multiple regression analysis, and utilize computer software in manipulation of data
Prepare and maintain SOPs (Standard Operating Procedures) for the Stability group
Adhere to the regulatory guidelines (cGMPs) that govern the manufacture, storage, testing and reporting of dietary supplements
Initiate analytical testing requests and analytical investigations to confirm product compliance.
Document and publish results as appropriate
Investigate out-of-specification results, and alert appropriate parties of the findings, and reassign expiry dates as necessary
Collect and compile information to be used for international registration of products, internal and external compliance audits, and customer complaints
Provide guidance and training to stability staff
Prepare and maintain SOPs. Prepare protocols/reports/regulatory filing documents.
Identify and facilitate continuous improvement to the Stability Program.
Analyze stability data for potential trends and provide statistical data reports: collect, manipulate, and interpret trends using simple and multiple regression analysis such as ANOVA, Linear and Non-Linear Regression.
Conduct in-house sensory panels. Design and perform special protocols for: sensory evaluations; photo stability; temp excursion; freeze/thaw; and bulk hold/ shipping, etc.
Construct special studies to test products in various climatic zones.
Maintain a compliant, audit ready LIMS stability data base. Perform data-entry.
Utilize computer software (EXCEL or SLIM) in manipulation of data, reporting and approving test results.
Work with QC Labs on testing, and provide information to assist in routing/flow of samples. Provide the labs data to use for setting test specs and limits.
Make recommendations to PD and International with respect to formula changes.
Assist Packaging in designing and planning packaging components for special studies.
Lead the Stability Committee.
Conduct document reviews (Expiry and QPRs) for QA.
Collaborate with management of all departments to include Regulatory Affairs, Quality Assurance, Production, Purchasing, Marketing and Business Development to support stability.
Represent the company with regulatory officials using stability expertise.
Obtain retain samples, order customized contract testing and interpret results.
Provide digital images of products to assist the Complaint process.
- 10 years stability experience in quality compliance environment and a demonstrated knowledge of statistical analysis in FDA regulated industry.
Work experience with a variety of dosage forms: tablets, creams, liquids, RTDs, gummies, and capsules in FDA regulated industry.
- Requires BS in Scientific Discipline
- MS in Food Science, Chemistry or equivalent scientific discipline
Experience using statistical analysis, data reporting, and trending packages.
Proficiency with Microsoft Office, Excel, AS400, and associated applications.
Excellent teamwork and communication skills.
Ability to effectively represent the company with regulatory officials related to stability expertise and general regulatory knowledge.
Ability to use the principles of chemistry, biology and general scientific skills to analyze problems and develop solutions
Excellent technical writing skills
Working knowledge in SLIM is a plus
Work Environment: Office and Chamber Environment and on the Plant floor in Greenville, SC and Anderson, SC locations.
Travel: Minor travel between Nutra facilities and GNC operational locations.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This job description reflects management's assignment of essential job functions, which are not intended to be an exhaustive list of all responsibilities, duties and skills required.