Nature and Scope

The Sr. Quality Engineer must demonstrate a sound knowledge, application, and proper implementation of the technical, quality, and scientific principals necessary to meet industry and customer requirements. The Sr. Quality Engineer has the primary responsibility for providing Quality Assurance input for the preparation/review of protocols and reports for the validation and implementation of complex utilities, systems, and equipment to support manufacturing, laboratory, and Quality Assurance processes.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Preparation/review of Quality Assurance, Validation, and Quality Control protocols and reports covering complex systems.
Works closely with members of other departments to accomplish overall objectives; and understand cGMP, and other FDA Guidance Documents, as well as the current processes and practices.
Work independently with minimal supervision as the Quality Assurance representative.
Identify key quality issues and assist their resolution.
Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

Bachelor’s degree in engineering, science, or computer science related discipline, preferred.

Minimum of 6 years of experience preferred in computer system validation or related areas.

Strong working knowledge of cGMP and Federal (FDA) requirements and guidelines, including CFR Part 11 and GAMP 5.
Strong technical writing skills and knowledge of Good Documentation Practices.
Experience with Microsoft Word, Excel, and Access required.
Experience with TrackWise, preferred.

Physical Environment and Requirements

While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.
Ability to work in an office environment including extensive computer activity.

Expected salary range:

$97,600 - $110,000

The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.