Senior Associate, Quality Engineer

Job Title: Sr. Associate, Quality Engineer

Department: Quality Assurance

Reporting To: Director, Quality and Compliance

Classification: Exempt

Salary Range: 95k-105k

What We Do

BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in Irvine, CA. Our 10 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.

Why BioDuro-Sundia?

Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

Job Overview/Summary

• Execute the daily activities for Quality Engineering functions.

Essential Functions and Responsibilities

• Oversee the cleaning validation program.
• Create cleaning verification protocols.
• write reports for cleaning validation for new products.
• Oversee the equipment qualification program.
• Plan utilities testing biannually and write reports.
• Utilize LIMS and BMRAM for updates and also pulling data for trending purposes.
• This job description is subject to change at any time.

Requirements

• B.S. Degree in Engineering or Science
• 8-10 years of industry experience
• knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, and / or Six-Sigma
• Technical skills
• Physical Demands
• CQE preferred.
• Cleaning validation and equipment qualification experience
• Proficient in Change control process
• Working independently to pull and trend data and write reports.
• Physical & mental requirements
• e.g. lift 20 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

Preferred Qualifications

• Must be collaborative and work in a fast passed CRDMO environment.
• Ability to work with clients and also support client/health authority audits by representing QA.
• Advice other teams on QE activities and utilize project management skills for biannual and annual activities.

Benefits

We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro-Sundia provides employees with a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.

EOE and Accommodation

We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro-Sundia provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing humanresources@BioDuro-Sundia.com. If you are selected to interview for a position, you may also request an accommodation with our team directly.

Notice to Agency and Search Firm Representatives

BioDuro-Sundia is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any BioDuro-Sundia employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of BioDuro-Sundia. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.