Job description

Job Title: Senior Quality Assurance Validation Specialist
Department: Quality
Reporting to: Senior Manager, Compliance and Customer Quality
Location: Remote (Periodic travel to Connecticut required; limited travel to Kentucky required, as appropriate)

Greenfield is looking for a Senior Quality Assurance Validation Specialist to join our growing team.

The Senior QA Validation Specialist is responsible for ensuring that validation activities of facility equipment and systems, laboratory instrumentation and systems, and computerized systems at the Greenfield Global Brookfield and Shelbyville sites comply with the appropriate internal procedures and regulatory guidelines.

Who We Are:
Greenfield Global is a leading producer and supplier of high-value, mission-critical raw materials, ingredients, and additives that are vital to businesses and integral to a lower-carbon economy. From start-ups to the largest brands in the world, customers trust Greenfield’s extensive portfolio of premium products, regulatory expertise, and industry-leading service to improve people’s lives and the health of the planet.

Why Join Greenfield?
We innovate, collaborate, and work with purpose. By unlocking the potential of people, partnerships, and nature to accelerate sustainable solutions for the health of the planet, our work has a positive impact on the environment around the world. We’re always looking for people who can bring new talents and experience to our team.

Who You Are:

• Possesses Company values of honesty, integrity, respect, commitment and open to change while modelling the Company Core Principles in all activities
• Ability to foster collaborative, cross department relationships to meet common objectives.
• Ability to understand and communicate regulatory requirements

Your Experience Should Include:

• Education: BS in science or related field or equivalent
• 5 years of validation system experience in a cGMP environment or equivalent
• Experience in establishing and maintaining a validation quality system preferred
• Experience with management of change, deviation investigation, and successful communications with regulatory authorities preferred.
• Knowledge of excipient regulatory guidance (IPEC, USP, EP, JP) preferred
• Proficient in Excel and Word
• Strong communication and interpersonal skills
• Strong organization and time-management skills
• Strong attention to detail

Job Responsibilities:

• Maintain validation procedures consistent with appropriate excipient regulatory guidance
• Develop and maintain knowledge of various validation requirements specific to the excipient industry, as required, i.e., IPEC, USP, EP, JP, ISO, etc.
• Develop validation and qualification protocols in collaboration with appropriate Subject Matter Experts (SMEs)
• Reviews and approves 3rd party validation protocols and reports
• Train personnel on validation protocols and assist with execution of the same, as appropriate
• Evaluate validation data and draft validation reports in collaboration with appropriate SMEs
• Review and approve proposed changes related to product, facility, laboratory, or computer systems
• Review and approve discrepancies associated with validation and qualification activities
• Support operations, laboratory, and computer system deviations and complaints involving validated systems, as appropriate
• Act as the primary SME for validation processes and procedures during regulatory and customer audits
• Perform additional duties as required

Total Compensation & Care:

• Base salary dependent on experience and demonstrated performance
• Formal and informal training opportunities
• Comprehensive health and dental benefits
• Income protection: short- and long-term disability coverage, life insurance, paid personal sick time
• Vacation time exceeding industry standards
• Company funded retirement savings program with individual contribution opportunities
• Meaningful and challenging work
• Curated intentional culture focused on growth and development, engagement, and communication

About Us
We own and operate five distilleries, four specialty chemical manufacturing and packaging plants, and three next-generation biofuel and renewable energy R&D centers. This integrated model enhances supply chain transparency, quality control, custom formulation development, and ultimately customer satisfaction.

Core Values

• Honesty
• Integrity
• Respect
• Commitment
• Openness to Change

Core Principles

• Innovation: We are constantly seizing opportunities to develop new products, processes and methods to meet the diverse and demanding requirements of our customers.
• Collaboration: We are part catalyst, part collaborator. We work with partners to get the most out of our existing products, and to develop custom solutions for our customer requirements.
• Responsibility: Our commitment to give back to local communities in the US and Canada goes beyond the bottom line. We give back to the planet by processing renewable resources into low carbon fuels and chemicals.
• Agility: Our team is not only fast, we has the flexibility and creativity to pivot with customer needs to develop custom-made, on-time solutions.
• Discipline: At every plant, and for every customer, for every shipment, we put quality first. We operate a tight, transparent supply chain while meeting the highest regulatory standards.

Greenfield Global USA, Inc. is an equal opportunity employer that is committed to providing a workplace free from harassment and discrimination. All qualified applicants for employment will be considered without regard to race, color, religion, sex, sexual orientation, marital or domestic partner status, gender identity or expression, pregnancy, age, national origin, ancestry, disability status, genetic information, veteran status, or any other legally protected characteristic.

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