QA Engineer I - Change Management
About The Position
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment.
Requirements
- Minimum Required Education: HS Diploma/ GED and 2+ years of relevant QA experience
- Bachelor's degree preferred in Chemistry, Biology, Biotechnology, Engineering, or related scientific/technical field
- Experience in pharmaceutical, medical device or regulated industry preferred
- Additional certifications in Quality Systems or GMP preferred
- Experience with quality systems and documentation including batch records, SOPs, deviations, CAPA
- Proficiency in quality management software systems (TrackWise, SAP, etc.)
- Experience conducting internal quality audits and supporting external regulatory audits
- Experience with continuous improvement methodologies (Lean, Six Sigma) preferred
- Demonstrated ability to perform detailed documentation review and quality assessments
- Strong analytical and problem-solving skills for quality investigations and root cause analysis
- Strong knowledge of cGMP, ISO standards (13485/9001), and international regulatory requirements
- Excellent written and verbal communication skills
- Ability to work independently and collaborate effectively with cross-functional teams
- Proficient computer skills including Microsoft Office applications
- Strong attention to detail and commitment to accuracy
- Ability to prioritize and adapt in a changing environment
- May require up to 10% travel
- Must be able to work in controlled environments wearing required PPE
Nice To Haves
- Bachelor's degree preferred in Chemistry, Biology, Biotechnology, Engineering, or related scientific/technical field
- Experience in pharmaceutical, medical device or regulated industry preferred
- Additional certifications in Quality Systems or GMP preferred
- Experience with continuous improvement methodologies (Lean, Six Sigma) preferred
Responsibilities
- 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.
Benefits
- Competitive Salary: Pay rate based on experience
- Annual performance-based bonus
- Annual merit performance-based increase
- Excellent Benefits!
- Medical, Dental, & Vision benefits-effective Day 1
- Paid Time Off (120 hours per year) + Designated Paid Holidays
- 401K Company Match up to 6%
- Tuition Reimbursement – eligible after 90 days!
- Employee Referral Bonus
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
