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.
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.
Education and Experience:
- 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
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
Knowledge, Skills and Abilities:
- 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
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
What We Offer
Competitive Salary:
- Pay rate based on experience
- Annual performance-based bonus
- Annual merit performance-based increase
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
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
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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
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: