Overview
Process Inspector (Union job) Jobs in North Grafton, MA at Wyman Gordon
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Summary of Job Responsibilities:
Quality Systems
Ensure compliance with Good Manufacturing Practices and corporate policies with special attention to the following:
Participate and/or lead project initiatives to optimize Quality Systems.
Support internal audits and regulatory inspections.
Ensure that site Self Inspection Program is in compliance. Monitor that action plans are created and implemented for any deficiency identified.
Keep management informed through periodic reports of the state of compliance of the quality systems and through metrics reporting (deviations, complaints, quality metrics, etc.).
Serve as instructor of Quality general procedures, serving as an educator and facilitator of GMPs, if required.
Compliance
Ensure site complies with laws and regulations from the Puerto Rico Department of Health.
Participate in the cross functional team working to ensure laws and regulations from regulatory bodies related to manufacturing of drug products are met.
Interact with regulatory agencies during inspections related to GMP.
Comply with all established requirements to receive and maintain authorization to handle controlled substances.
Basic Requirements:
Masters or Doctor degree in Pharmacy degree
Valid PR Pharmacist License from the Department of Health or in progress of licensing
3-5 years of experience working in a pharma manufacturing regulated environment in areas like Manufacturing, Technical Services, Quality and/or compliance areas.
Comprehensive understanding of cGMP regulations, quality control processes, and industry standards.
Experience managing deviations, change controls, batch disposition, batch record review, among others.
Experience interacting with regulatory bodies and inspectors.
Fully bilingual (English and Spanish)
Additional Preferences:
Understanding and working knowledge of inspection readiness, QA Compliance area, and technical writing.
Ability to work on multiple simultaneous initiatives according to area needs.
Strong compliance and sound judgement
Ability to connect with others at all levels of the organization
Teamwork oriented
Attention to details, analytical-technical thinking/mindset, and problem-solving skills
Availability to support a 24/7 operation, if needed
Salary commensurate with experience.
Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 – $115,500
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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Title: Process Inspector (Union job)
Company: Wyman Gordon
Location: North Grafton, MA
