Engineer I, QA

Work Schedule

Environmental Conditions

Job Description

Join Thermo Fisher Scientific in making a real-world impact by supporting the development and manufacturing of life-saving biological-based therapeutics and vaccines. You'll play a vital role in ensuring flawless quality standards and collaborating with a team of exceptionally dedicated professionals!

BioProduction supports the development of biologics with a world-class portfolio of solutions and services. Our division is at the forefront of the fight against the coronavirus pandemic, making a significant global impact.

Monday-Friday- First Shift

We are seeking a dedicated professional to draft, review, and finalize Change Notifications with customers across multiple sites within BCD.

Key Objectives of the Role:

• The key responsibilities of this role will include, draft, review, and finalize Change Notifications with customers for multiple BCD sites. Actively support and handle change management and notification activities relating to the Grand Island and BCD business processes.
• Address complex quality issues directly with customers and support issue resolution.
• Assist in the creation and modification of processes and procedures to ensure their efficiency.
• Participate in multi-functional projects of moderate scope to support the BCD Quality Management System.
• Drive continuous improvement initiatives to ensure the effective implementation of the QMS.
• Ensure the BCD Quality Management System maintains consistent product quality and regulatory compliance.

Knowledge and Skills:

• Strong proven understanding of compliance with quality standards (e.g., EU GMP, 21 CFR Part 210, 211, 820, ISO 13485, 9001, MDSAP).
• Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.).
• Familiarity and proficiency with global systems such as Trackwise, ORACLE, and E1/SAP.

Minimum Qualifications:

• Bachelor’s degree in a science field with 1-3 years of experience in a quality function within a regulated environment,
• High School Diploma or GED with 3-5 years of relevant quality experience in the Medical Device or Pharmaceutical industry, or comparable professional experience.
• Familiarity with quality standards (e.g., 21 CFR Part 820, ISO 13485 ISO 9001).

Working Conditions:

Works in an office environment. May be required to work overtime to complete tasks if required.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards