Quality Technician

West Pharmaceutical Services, Inc; United States; On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Generous PTO

Bonuses

Global career opportunities

Job summary

West Pharmaceutical Services, Inc. is seeking a Lab Operations Data Reviewer on 2nd shift to independently analyze data generated for internal and external customers and support post-production QA activities, including finished batch release, sterilization, packaging specifics, and device history documentation.

The role requires knowledge of current regulations, familiarity with SAP, LIMS, and MasterControl, and the ability to work with cross-functional teams.

Qualifications

• No minimum work experience required.
• 1+ year in cGMP environment utilizing SAP preferred.

Responsibilities

• Perform cGMP Data Review on analytical data from Lab Operations.
• Review data per methods, protocols, and Work Instructions for compliance.
• Review Electronic Data and Audit Trails for data integrity.
• Review batch release documentation and Certificate of Compliance.
• Initiate SAP steps related to batch release and sterilization processes.

Skills

cGMP Data Review

SAP

LIMS

Data Integrity

Education

High school diploma or GED

Tools

MS Office

MasterControl

Laboratory Information Systems

Job description

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.

Shift

• 2nd Shift (Monday - Friday from 2 PM - 10:30 PM)

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/investigation.
• Review the analytical raw data generated by laboratory operations according to established methods, protocols, Compendia and Work Instructions for cGMP compliance.
• Review Electronic Data and Audit Trails for data integrity compliance.
• Review Lab Operations Methods, Protocols, and Work Instructions for cGMP Compliance.
• Responsible 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 artwork.
• Maintain working knowledge of computer software packages including MS Office suite, Adobe, MasterControl, LIMS, and LMS.
• Collaborate as needed on proposed path forward regarding documentation questions.
• Support preparations for periodical management reviews.
• Initiate processes in SAP as needed related to finished batch release and sterilization processes.

Additional 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 procedures.
• Support new GMP compliance guidance and Data Integrity initiatives.

Education

• High school diploma or GED required.

Work Experience

• No minimum work experience required.
• Minimum 1+ year in cGMP environment utilizing SAP preferred.

Additional Requirements

• Basic to moderate understanding of English required.
• Read and interpret data, information, documents, and technical writing required.

Preferred Knowledge, Skills and Abilities

• Able to be aware of all relevant standard operating procedures as per Company policy.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
• Willingness to learn new and review new analytical techniques.
• Meet individual and departmental goals as required.

Physical 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.

Travel Requirements

• 5%: Up to 13 business days per year

What We Offer

• Generous Paid Time Off (PTO):
• Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.
• Recognition & Rewards:
• Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.
• Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
• Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill‑certification initiatives.
• Global Career Opportunities: With facilities across North America, Europe, and Asia‑Pacific, employees have opportunities for international exposure and cross-functional collaboration.
• Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.

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.