Title:  Product Release Specialist

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  
 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  
 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  
 

2nd Shift – M-F 1pm to 10pm

Job Summary:

In this role, the employee will be responsible for the review and approval of batch production records and accompanying documentation. The employee shall ensure all documentation and information is accurate and in compliance with necessary requirements prior to its release for use and/or shipment.  The employee will also be responsible for ensuring good documentations practices are adhered to and corrections are made when necessary. 

Essential Duties and Responsibilities:

•    Review incoming batch records to ensure compliance to all internal and external key quality attributes and release in electronic management system (EMS).
•    Ensure the quality release of production/Incoming batches is performed appropriately and expediently.
•    Serve as leader and mentor to other Incoming Quality team members and counsel them on best practices, Quality concepts, and decision making.

•    Review metrology data and ensure other input documentation required for batch release is up to date.
•    Communicate review results to Production and Quality management in a timely manner.
•    Report recurring quality and/or documentation issues to relevant personnel, supervisors, and management in a respectful and collaborative manner. 
•    Assists shift employees with identifying quality issues and assists in course of action to resolve issues.
•    Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
•    Exhibits regular, reliable, punctual and predictable attendance.
•    Be willing and able to flex to other Quality areas and responsibilities, as needed and directed.
•    Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
•    Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
 

Basic Qualifications: 

Education or Equivalent Experience: Bachelor's in related field of study or equivalent. 
•    Experience: 3-5 years of experience of progressive experience in Quality Assurance in GMP FDA environment, preferably pharmaceuticals.
•    In-depth understanding of cGMP’s in drug handling facilities. 
•    Ability to communicate knowledgeably about quality and technical issues.
•    This position requires ability to utilize computer programs such as Microsoft suite, EMS, and other relevant electronic applications.

Preferred Knowledge, Skills and Abilities:

•    Previous experience in Quality Assurance/Quality Control preferred
•    Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
•    Able to comply with the company’s safety policy at all times
•    Able to comply with the company’s quality policy at all times. 
•    Support and contribute in Lean Sigma programs and activities towards delivery of the set target 
•    Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description 

Travel Requirements:

•    No travel required.

Physical & Mental Requirements:

•    Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events. 
•    Maintain high attention to detail, accuracy, and overall quality of work.
•    Effectively communicate and interface with various levels internally and with customers.
•    Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description 
•    Performing the duties of this job may involve the employee walking, standing on concrete floor, sitting for extended periods, lifting of cartons, containers or bags of product.  

     The employee must be able to maintain concentration and visual acuity on tasks for extended periods.

•    The employee must occasionally lift and/or move up to 35 pounds.  

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West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.