Primary Objective of Position
The QC Stability Coordinator is responsible for administering and directing all aspects of the Recro Gainesville stability program. This includes the preparation of the stability statistical summary section of the APR, data trend analysis, expiration dating, as well as directing the site stability program including study management, sample pulls, sample/study initiations, regulatory compliance, and data management/analysis. He/She will ensure that the systems are efficient and engineered to provide quality data in a timely fashion. He/She is responsible for coordinating all activities including stability alerts with Quality Control, Quality Assurance, Regulatory Affairs, Materials Management, and Manufacturing. He/She is responsible for directing the enrollment of batches of material into the stability program to satisfy regulatory, validation commitments, and special customer needs.
Stability Program (50%)
• Direct the maintenance of stability information, including preparing and maintaining written stability protocols for each product formulation, the stability database and trend analysis and interpretation for each product formulation.
• Represent Stability as the site expert on core teams for production projects and act as internal point person for all stability related issues including all stability investigations.
• Initiation and management of all stability studies within SLIM database.
• Manage/perform sample initiation and corresponding sample pulls (aliquotting, labeling, and distribution into appropriate stability chambers).
• Maintains stability chamber inventory and monitors chamber performance.
• Respond on a 24/7 basis to changes in stability chamber conditions.
Regulatory Role (30%)
• Prepare the stability statistical portion of the annual product review for regulatory affairs annual submission, which includes the preparation of stability data graphs per FDA guidelines to estimate expiration dates, trend analysis and interpretation.
• Understanding and support of early development phases of new products with respect to early phase and clinical stability studies.
• Anticipate regulatory consequences – develop and maintain knowledge of the history, manufacture, and materials of assigned products and product lines in order to assess the stability consequences of changes in manufacture, materials or marketing of the product and participation in stability alerts.
Data Management (10%)
• Analyze and interpret statistical data including but not limited to regression analysis, data pooling, expiration data and the identification of trends.
• Interact and advise lab management in investigation of atypical or OOS stability results. Also provides notification of all chamber excursions and subsequent corrective actions to laboratory management.
• Interact with internal and external auditors as well as external customers or functional groups. May be required to act as spokesperson or subject matter expert on behalf of company.
• Present scientific information to management and regulatory agencies.
• Responsible for ensuring stability chambers and monitoring system are performing within set requirements.
• Responsible for quarterly inventory of controlled stability samples.
• Responsible for providing continued evaluation of current processes and procedures for the stability program and recommending improvements to management.
Minimum Job Qualifications
Bachelor’s degree in chemistry, or similar scientific field.
Minimum of seven years of work experience in pharmaceutical QA and/or QC laboratory environment required.
Strong understanding or previous demonstrated experience in pharmaceutical stability programs and processes is highly preferred.
Working knowledge of cGMPs in an FDA regulated environment is required.
• Knowledge of and ability to work with equipment, supplies, components and technical areas that are utilized in the pharmaceutical industry, i.e. lab testing equipment, weighing equipment and controlled environmental chambers.
• Knowledge of microbiology testing and analysis is a plus.
• Knowledge of FDA guidelines regarding Stability requirements is a plus.
• Able to work with minimal guidance to take a project from start to finish.
• Ability to handle routine details and unexpected changes without losing focus on own projects.
• Ability to determine task priority and maintain established deadlines for regulatory submissions.
• Ability to work well in project loaded, constantly changing environment.
• Requires strong interpersonal and communication (written and oral) skills and the ability to interact effectively with peers and upper management.
• Exceptional organizational skills required.
• This position requires frequent interaction with manufacturing, quality, materials management and regulatory affairs.
Physical and Mental Demands and Work Environment
The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus. While performing the duties of this job, the employee is frequently required to stand, walk and sit.
While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; interact appropriately with staff, management contractors, vendors and others encountered in the course of work; read and interpret a variety of documents and instructions furnished in written, oral, diagram, or schedule form such as safety rules, operating and maintenance instructions, and procedure manuals; interpret technical and engineering data; generate technical reports of investigations; analyze and solve practical problems and deal with a variety of concrete variables; establish priorities and work on multiple assignments and projects concurrently.
The employee is regularly required to apply computer skills covering word processing, spreadsheet and presentation software.
The employee is regularly required to apply mathematical formulae and engineering rules of thumb to tasks and execute technical and engineering calculations.
In certain assignments, the employee will occasionally work with and around fumes or airborne particles, and toxic or caustic chemicals. The employee must be able to wear appropriate personal protective equipment such as a respirator.
The noise level in the work environment is usually moderate.