Quality Operations Specialist

NCBiotech; Northern (KY); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) with match

Parental leave

Paid time off

Company holidays

LinkedIn Learning

Career growth opportunities

Job summary

Gilero, a Sanner Group company, seeks a Quality Operations Specialist to support the Pittsboro, NC facility, bridging development and commercial manufacturing. You will coordinate documentation, perform inspections, and support CAPA, audits, and continuous improvement initiatives.

The role requires a bachelor’s degree and 0–5 years in a regulated manufacturing environment, with preference for 5+ years in medical device manufacturing and knowledge of GMP/GxP concepts.

Qualifications

• Bachelor’s degree or equivalent combination of education and experience.
• 0 - 5 years in regulated manufacturing environment
• Experience with FDA 820 CFRs/ISO 13485/cGMP quality management system requirements and medical devices/combination product development
• Basic experience with coordination of GMP compliant Documents, Records, and Training
• Strong written and verbal communication skills
• Preferred: 5+ years in medical device manufacturing
• Experience with quality operations, design transfer and GxP concepts
• Experience with GMP manufacturing operations and process development
• ASQ or related certification

Responsibilities

• Liaise between product development and manufacturing project teams to ensure compliant design transfer
• Coordinate, assemble, and route documentation per quality system lifecycle requirements
• Perform incoming inspection/testing and release of accepted materials
• Perform pilot builds in cooperation with operations and design transfer teams
• Conduct labeling verification in accordance with product requirements
• Perform in-process testing and QA inspections per product requirements
• Coordinate environmental monitoring, including particle counts and temperature/humidity/pressure measurements
• Coordinate cleaning of controlled environment areas per internal procedures
• Manage third-party environmental testing and approve results
• Support sterilization coordination
• Review batch records for accuracy and completeness. Collaborate with manufacturing and development teams to resolve any batch documentation-related errors or gaps
• Support quality event initiation and investigation for nonconformances, CAPA, change control and complaints.
• Support continuous improvement projects and audits

Skills

Communication skills

Regulatory knowledge

Medical devices

GxP concepts

Education

Bachelor’s degree or equivalent

Job description

Do you have a passion for helping bring innovative medical devices and drug delivery products to market that improve patient lives? Gilero, a Sanner Group company, is seeking an experienced Quality Operations Specialist to support our Pittsboro, NC facility. You will be responsible for Quality Operations to support transition between development and commercial manufacturing activities.

Duties

• Liaise between product development and manufacturing project teams to ensure compliant design transfer
• Coordinate, assemble, and route documentation per quality system lifecycle requirements
• Perform incoming inspection/testing and release of accepted materials
• Perform pilot builds in cooperation with operations and design transfer teams
• Conduct labeling verification in accordance with product requirements
• Perform in-process testing and QA inspections per product requirements
• Coordinate environmental monitoring, including particle counts and temperature/humidity/pressure measurements
• Coordinate cleaning of controlled environment areas per internal procedures
• Manage third-party environmental testing and approve results
• Support sterilization coordination
• Review batch records for accuracy and completeness. Collaborate with manufacturing and development teams to resolve any batch documentation-related errors or gaps
• Support quality event initiation and investigation for nonconformances, CAPA, change control and complaints.
• Support continuous improvement projects and audits

Skills/Qualifications

• Bachelor’s degree or equivalent combination of education and experience.
• 0 - 5 years in regulated manufacturing environment
• Experience with FDA 820 CFRs/ISO 13485/cGMP quality management system requirements and medical devices/combination product development
• Basic experience with coordination of GMP compliant Documents, Records, and Training
• Strong written and verbal communication skills
• Preferred:
• 5+ years in medical device manufacturing
• Experience with quality operations, design transfer and GxP concepts
• Experience with GMP manufacturing operations and process development
• ASQ or related certification

Personal Attributes

• Meets Gilero Core Values: Collaboration, Innovation, Excellence, Integrity
• Productive in a fast-paced, entrepreneurial environment.
• Commits to excellence and quality service to external and internal customers.
• Adheres to established policies and procedures, while contributing to continuous improvements.

Eligibility To Work

• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Gilero does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires.

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our teams continue to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Durham, Greensboro, and Pittsboro.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), dental and vision, company provided life insurance, short-term and long-term disability, 401(k) with a match the first month after you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.

What We Offer

• Competitive base salary plus incentive compensation
• Annual performance bonus
• Medical, dental, and vision insurance (multiple BCBS medical plan options)
• Company paid life insurance, short- and long-term disability coverage
• 401(k) with company match beginning the first month after you start and immediate vesting in company match
• Paid parental leave
• Paid Time Off and company holidays
• LinkedIn Learning for professional development
• Career growth opportunities within Gilero and the global Sanner Group