Shire Jobs

Description

Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

The Stability Specialist is responsible for the planning, tracking and operation of all stability studies on site. This job requires the ability to demonstrate a high commitment to interpersonal relations. The Stability Specialist reports to Quality Assurance (QA) management and works closely with Quality Control and Microbiology Department Management.

This position presents the employee with an opportunity to play a key role in stability studies which includes study creation, study management, sample pulls, sample/study initiation, analytical testing, regulatory compliance and data management, while simultaneously learning the technical skills required to advance in the field of stability studies.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

At all times, comply with PDI Code of Integrity and Professional Conduct

• Performs a variety of activities to help administer the stability program at PDI

• Responds to customer requests for information concerning stability studies

• Collaborates with R&D, Planning and QA in the initial drafting and revision of stability protocols and final reports

• Prepares and reviews final stability data summary reports, as well as performs any needed stability trending as outlined in the stability protocol, for Annual Product Review (APR and those associated with specific product and process investigations.

• Assess current processes and provide solutions for increasing efficiency and regulatory compliance

• Performs investigations related to stability storage conditions being out of limits and assists in data evaluation associated with product/process investigations

• Writes deviations, OOS and NC/CAPA investigations/reports

• Prepares samples for inclusion in stability studies, including labeling and distribution to the appropriate stability chamber

• Removes samples from stability chambers according to protocol pull schedules and submits them to the appropriate testing group or outside customer

• Maintains stability chamber inventory and monitors chamber performance

• Utilizes a Laboratory Information Management Software (e.g. Labware LIMS) to manage and track studies to completion

• Perform quarterly inventory of stability samples, special attention to control samples. Maintains thorough knowledge and understanding of all Standard Operating procedures (SOPs) pertaining to testing, review, and equipment calibration and maintenance.

• Maintains thorough knowledge and understanding of general SOPs, GMP/GLP and ISO regulations as it pertains to work performed in the laboratory.

• Maintains knowledge of current compendia and testing methods as they apply to stability studies and knowledge of FDA guidelines regarding stability requirements.

• Able to work with minimal guidance to take a project from start to finish

• Adherence to relevant SOPs governing documentation.

• Adherence to applicable PDI personnel policies

• Participation in general staff meetings and training sessions as scheduled by QC Laboratory Management.

• Other duties as assigned

PERFORMANCE MEASUREMENTS

• Development and execution of stability related processes which enable rapid product development, product commercialization, product quality and operational excellence.

• Stability testing and reports are completed on time per procedure

• Internal and external customer requests for stability data / reports are provided in a timely manner

QUALIFICATIONS

EDUCATION/CERTIFICATION:

• BA/BS in a scientific field or equivalent job experience required.

• Thorough knowledge of scientific principles required.

REQUIRED KNOWLEDGE:

• Proficient knowledge of cGMPs as they pertain to a production facility, manufacturing and packaging processes, and quality compliance in an FDA regulated environment

• Previous experience with administration of a stability program

EXPERIENCE REQUIRED:

• Minimum five (5) years relevant laboratory and or QA experience in a regulated environment with great understanding or previously demonstrated experience in pharmaceutical stability programs and processes.

SKILLS/ABILITIES:

• Ability to work independently on Quality stability projects and initiatives with minimum supervision.

• Pro-active in identifying opportunities along with strong problem solving and negotiation skills.

• Ability to work "hands on" in an entrepreneurial, fast paced environment.

• Leads by example and highly collaborative with the proven ability to work in a cross-functional team.

• Self-starter and team player with strong leadership, administrative, interpersonal, and team-building skills.

• Strong verbal, written communication skills and computer skills are required.

• Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word

• Knowledge and previous experience with data analysis software tools including Minitab is preferred.

• Must be goal-oriented, quality-conscientious, and customer-focused.

WORKING CONDITIONS

• No hazardous or significantly unpleasant conditions.

SALARY RANGE

• $65,000 - $70,000 annually

PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes:

• Medical & prescription drug coverage

• Dental / Vision plan

• 401(k) savings plan with company match

• Basic and supplemental life insurance

• Flexible Spending Accounts (FSAs)

• Short- and long-term disability benefits

• Health Advocacy Program / Employee Assistance Program (EAP)

Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)