Quality Specialist, Batch Record Position Available In Lenoir, North Carolina

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. Job Summary In this role you will be responsible to independently provide analytical review of the data generated for internal and external customers as well as supporting post-production related Quality activities such as finished batch release, including sterilization, packaging specifics, work order approval and support additional quality department activities. This position also requires maintaining knowledge of the current local and/or International regulations/guidelines/policies applicable to West’s products and services.

Essential Duties and Responsibilities Perform cGMP Data Review on the analytical data generated in Lab Operations which may include raw materials and finished goods, product performance, container closure integrity, particle analysis, and/or microscopy/investigationReview the analytical raw data generated by laboratory operations according to established methods, protocols, Compendia and Work Instructions for cGMP complianceReview Electronic Data and Audit Trails for data integrity complianceReview Lab Operations Methods, Protocols, and Work Instructions for cGMP ComplianceResponsible to review and approve of samples and / or batch release including review and approval of the finished Device History File documentation and Certificate of Compliance issuing.

Responsible to review and approve of relevant packaging and respective graphics artworkMaintain working knowledge of computer software packages including MS Office suite, Adobe, MasterControl, LIMS, and LMSCollaborate as needed on proposed path forward regarding documentation questionsSupport preparations for periodical management reviewsInitiate processes in SAP as needed related to finished batch release and sterilization processesAdditional Responsibilities Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.

Maintain a clean, orderly, and safe workstation and environment at all times.

Conform with and abide by all regulations, policies, work procedures, instruction, and safety rules.

Exhibit regular, reliable, and punctual attendance.

Perform other duties as assigned based on business needs.

Keep current with new GMP compliance guidance and internal QA proceduresSupport new GMP compliance guidance and Data Integrity initiatives Education Bachelor’s Degree Technical Studies or Science or equivalent experience preferred Work Experience No min required years of experience required 2 years of cGMP experience preferred Preferred Knowledge, Skills and Abilities Able to be aware of all relevant standard operating procedures as per Company policySupport and contribute to Lean Sigma programs and activities towards delivery of the set targetPossess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitudeWillingness to learn new and review new analytical techniquesMeet individual and departmental goals as requiredLicense and Certifications Travel Requirements 5%: Up to 13 business days per yearPhysical Requirements Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.

Additional Requirements Ability to learn, understand, and remember normal tasks.
Ability to hear, speak, and understand conversation in English in a normal tone of voice.
Must maintain the ability to work well with others in a variety of situations.
Must be able to multi-task, work under time constraints, problem solve, and prioritize.
Read and interpret data, information and documents
Work under deadlines with constant interruptions #LI-TH1 West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.

Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.