Sr. Quality Assurance - Engineer

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.

Organization Overview: The Quality engineer facilitates and enforces compliance with Good Manufacturing Practices (GMP) and corporate quality policies at the PR01 plant, focusing on utilities, equipment, computerized systems, and facilities in oral solid manufacturing. As part of the role will support project implementation for the site in all phases ensuring compliance with requirements and regulations. Support and oversight as Quality Unit for qualifications and all related documentation.

Responsibilities:Ensure compliance with Good Manufacturing Practices (GMPs) and corporate quality policies with special attention to the following elements:• Participating in qualification strategies, change control evaluations, deviation assessments, periodic quality evaluations, procedure management, and documentation retention

• Fulfill individual training plans, act as a quality procedure instructor and mentor, actively participate in Flow Team activities, and attend departmental meetings

• Monitoring pest control and facility maintenance, supporting Lean implementation, evaluating validations and changes related to utilities, equipment, and facilities, and ensuring regulatory plan approvals

• Ensures compliance with data integrity per 21 CFR Part 11, computerized system validation policies, and handles controlled substances according to legal and company requirements, including reporting deviations and illicit activities

Basic Requirements:

• Bachelor’s degree in Engineering (Chemical, Electrical or Mechanical)
• Minimum of 3 years of experience in facilities, equipment, utilities and FDA regulated environment.
• PE or EIT, preferred

Additional Skills/Preferences:

• Bilingual (English/Spanish) with strong written and oral communication skills
• Strong leadership and organizational skills
• Sound judgment
• Teamwork oriented; ability to work cross functionally
• Able to manage multiple project objectives or assignments
• Strong customer service focus

Additional Information:

• Able to work extended hours as applicable to support business needs

• Located at Carolina, PR

• This position is not permanent. It is for a fixed term position up to a maximum of 1 year.

• 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.

"Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1."

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

$52,500 - $154,000

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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