Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The In-Process Quality Engineer II– Stability performs essential duties in ensuring the Stability Program operates effectively and in compliance with US and International pharmaceutical manufacturing regulations/guidance documents.  The scope of responsibility includes packaging, storage and delivery of stability material in a timely manner to avoid undue burden on the testing laboratories, updating department Work Instructions or site Quality System Procedures and developing solutions to routine technical problems of limited scope to improve department efficiencies.

Job Description

ESSENTIAL FUNCTIONS:

• Responsible for ensuring required stability testing is performed as per procedures, and ensures timely data review for multiple sites
• Manages and maintains stability samples under ICH, FDA, DEA and cGMP regulations
• Pulls and delivers stability samples at testing intervals
• Package stability samples per study requirements for multiple sites
• Maintains controlled substance inventory in compliance with applicable DEA regulations
• Performs annual physical inventory of controlled substances
• Works with LIMS team to ensure stability module of LIMS system is maintained and functional
• Manages controlled and non-hazardous destruction inventory
• Evaluates analytical data and stability documentation for accuracy and completeness
• Provides statistical analysis of stability data
• Responsible for packaging, labeling, and storage of stability samples for multiple sites
• Creates stability study plans for all stability studies
• Create and review stability impact revision protocols
• Provide Stability support for sister sites
• Train new hires into the department as needed for OJT per the stability training curriculum
• Create product stability reports as requested
• Receives/approves bulk stability samples in the Biovia and ELN systems.
• Support the expansion of the stability program into the Zone IVB market.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• Shares responsibility for Stability Packaging functions and sample pulls as needed.
• Reviews and approves stability data sheets
• Fulfills regulatory stability requests

MINIMUM REQUIREMENTS:

Education:

BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies.

Experience:

Minimum of 1 year related experience in Quality stability programs.    Proven project management history.  Complete knowledge of pharmaceutical regulations including current GXP, GLP, or GMP requirements. 

Preferred Skills/Qualifications:

• Excellent communication skills. 
• Ability to work in and promote a team environment. 
• Understanding and application of principles, concepts, practices, and standards within discipline. 
• Knowledge of stability chambers and laboratory equipment. 
• Ability to read and interpret graphs.  
• Ability to lead and influence people.
• Understanding of basic statistical principles. 
• Understanding of analytical chemistry and OOS investigations. 
• Knowledge of US and international pharmaceutical manufacturing regulations/guidance documents

Other Skills:

Knowledge of ELN, LIMS, Excel, MiniTab. 

COMPETENCIES:

Dealing with Ambiguity, Approachability, Decision Quality, Functional/Technical Skills, and Integrity and Trust. Customer Focus

RELATIONSHIPS WITH OTHERS:

Works frequently with internal customers including QC, Manufacturing, Logistics, Regulatory, QA, Validation, APIDs, Maintenance/Engineering, and EHS.  Also serves as a representative during audits with customers, regulatory, and internal entities.

WORKING CONDITIONS:

• 50% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds. 
• 50% Office environment which includes sitting for long periods of time and computer use.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.