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    Cgmp Quality Specialist

    Strata-G Llc
    5+ years
    Preffered by Company
    Remote, USA
    10 Sept. 3, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: cGMP Quality Specialist

    Company Overview:

    At Strata-G, our impact is defined by the exceptional talent we hire, the strong relationships we build with our clients, and the positive contributions we make to our community. Our team of driven engineers, scientists, and business professionals collaborates to tackle complex energy and environmental challenges worldwide. Our core values foster a culture of meaningful change for both our clients and the world:

    • We Care: We treat our customers and employees with respect and empathy.
    • Integrity: We uphold honesty and ethical practices in all our endeavors.
    • Service: We aim to exceed customer expectations through relentless improvement.
    • Quality: We foster a culture of continuous enhancement.
    • Safety: We prioritize the health and safety of our associates, customers, the public, and the environment.
    • Innovation: We create inventive solutions to better serve our clients.
    • Attitude: We maintain a positive outlook and value humor.
    • Outreach: We share our successes with the community.

    Position Summary:

    Strata-G is seeking a seasoned cGMP Quality Specialist to ensure that radioisotopes intended for use as Active Pharmaceutical Ingredients (APIs) are produced under stringent controls and appropriate facility environments.

    Key Responsibilities:

    • Interpret and apply quality assurance requirements from 21 CFR 211 and ICH Q7 to work procedures and documentation.
    • Review and approve production batch records for the release of radioisotope products.
    • Develop and assess technical procedures and documents for QA compliance.
    • Oversee change controls related to processes, equipment, and facilities.
    • Maintain filings with the FDA and other regulatory agencies, including the Drug Master File.
    • Conduct cGMP training and develop strong internal and external relationships to address issues and concerns.
    • Guide the deployment of management systems and assist with non-conformance processing.
    • Evaluate assessment findings and improvement opportunities to ensure proper closure.
    • Collaborate with customers to meet goals and assess satisfaction.
    • Identify and resolve issues to achieve business results.

    Basic Qualifications:

    • Bachelor’s degree in Science, Quality Assurance, or a related field.
    • Minimum of five years of relevant quality experience; a combination of education and experience may be considered.
    • Knowledge of current Good Manufacturing Practices (cGMP) for drug manufacturing.
    • Ability to obtain and maintain a clearance from the Department of Energy, including passing a pre-placement drug test and participating in random drug testing.

    Preferred Qualifications:

    • Strong computer and organizational skills, with the ability to multitask effectively.
    • Excellent oral and written communication skills.
    • Experience with quality-related aspects of analytical methods such as gamma spectroscopy or inductively coupled plasma spectroscopy.
    • Experience in radioisotope production and with new facility design and environmental controls for manufacturing.
    • Familiarity with radioactive decay calculations.
    • Proven experience in quality assurance activities, including supporting regulatory and customer audits, investigating non-conformances, and implementing corrective actions.
    • Experience with document change control systems and evaluating changes against regulatory requirements.
    • Demonstrated ability to collaborate with internal and external organizations.
    • Experience in quality oversight of drug manufacturing, including production record approval and process validation.
    • Strong self-motivation, creativity, and passion with the ability to meet deliverables in a dynamic environment.

    Job Details:

    • Type: Contract (3 to 4 months)
    • Location: Oak Ridge, TN (Hybrid option available; onsite presence required as needed)

    Additional Information:

    Strata-G does not sponsor work visas. Candidates must provide evidence of identity and employment authorization. Drug testing and a potential background investigation by the Federal government may be required. Strata-G is an Equal Employment Opportunity (EEO) employer and provides equal opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veteran status, or disability. All job descriptions are evaluated based on physical/mental standards according to AAP guidelines.

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