At Strata-G, we define significance by the extraordinary people we hire, the relationships we build with our clients, and the positive impact we make in the community. Our team of intellectually curious and highly motivated engineers, scientists and business professionals engages with our clients to solve complex energy and environmental challenges around the world.

We are driven by our values to create a culture of significant and positive change for our clients and the world.

We Care We treat our customers and employees as we wish to be treated. Integrity We are honest and ethical in every endeavor. Service We continuously strive to please our customers and to exceed their expectations. Quality We maintain a culture of continuous improvement. Safety We hold paramount the safety and health of our associates, our customers, the public, and the environment. Innovation We develop creative solutions to better serve our customers. Attitude We maintain a positive attitude and value humor. Outreach We share the results of our successes with the community.

Strata-G is seeking an experienced cGMP Quality Specialist with the following:

Summary:

The Quality Representative ensures that the radioisotope intended for use as an Active Pharmaceutical Ingredient (API) is produced under appropriate controls and facility environments.

Major Duties & Responsibilities:

• Interpret quality assurance requirements provided in 21 CFR 211 and ICH Q7 and determine the appropriate application in work procedures and documents

• Review production batch records and perform final approval for release of radioisotope products for distribution

• Assist in the development of technical procedures and documents, and assess for implementation of QA requirements

• Oversee and evaluate planned change controls for changes to the process, equipment, facilities, etc.

• Maintain up-to-date filings with the Food and Drug Administration and other regulatory agencies, including maintenance of a Drug Master File

• Conduct cGMP training for the program

• Build and develop strong relationships with peers and others to exchange feedback on issues and concerns.

• Provide guidance for efficient and effective deployment of management systems

• Assist in the implementation of non-conformance processing.

• Review actions associated with assessment findings and opportunities for improvement to ensure objective evidence is sufficient to support closure.

• Establish relationships and work effectively with both external and internal customers to meet goals and assess customer satisfaction.

• Identify and/or solve problems, assessing needs to achieve desired business results.

Basic (Required) Qualifications:

• Position requires a bachelor's degree in Science, Quality Assurance, or a related field.

• A minimum of five years of relevant quality experience. An equivalent combination of education and experience may be considered.

• Working knowledge of current Good Manufacturing Practices (cGMP) for drug manufacturing.

• This position requires the ability to obtain and maintain a clearance from the Department of Energy. As such, this position is a Workplace Substance Abuse (WSAP) testing designated position. WSAP positions require passing a pre-placement drug test and participation in an ongoing random drug testing program.

Preferred Qualifications:

• Strong computer and organizational skills with the ability to multitask.

• Excellent oral and written communication skills.

• Experience with quality-related aspects of analytical methods including gamma spectroscopy, inductively coupled plasma spectroscopy, or similar analytical techniques.

• Experience with radioisotope production.

• Experience with new facility design and environmental controls for manufacturing.

• Experience with radioactive decay calculations.

• Working knowledge of and experience with quality assurance activities including supporting regulatory, customer, and performance audits, investigating non-conformances and deviations, recommending, and implementing corrective actions, providing complete and accurate documentation of quality activities through technical reports, and ensuring quality assurance compliance.

• Experience developing and managing document change control systems and performing necessary evaluations of proposed changes against regulatory filings and requirements.

• Experience successfully collaborating with internal and external organizations.

• Experience with quality oversight of drug manufacturing (e.g., approval of production records, process validation, etc.).

• Demonstrated experience in providing quality support to a technical organization.

• Extremely self-motivated, creative, and passionate with excellent written and oral communication skills and the ability to multi-task.

• Ability to meet deliverables in a fast-paced and dynamic team environment.

• Understand the basics of radioactive decay.

Job Type:

Contract - Duration is 3 to 4 months.

Job Location:

Oak Ridge, TN - Hybrid option is available. Will be required to be onsite as needed.

Strata-G will not sponsor applicants for immigrant or non-immigrant work visas. The successful candidate will be required to submit evidence of identity and employment authorization. Tests for the absence of any illegal drug as defined in 10 CFR 707.4, will be conducted by Strata-G and a background investigation by the Federal government may be required to obtain an access authorization prior to employment. Strata-G is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veteran or disabled status. All job descriptions are evaluated for physical/mental standards prior to posting based on AAP guidelines.