Cgmp Quality Specialist

0-5 years

Not Disclosed

Remote, USA

10 July 31, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

cGMP Quality Specialist

Location: Oak Ridge, TN (Hybrid option available; on-site presence as needed)
Contract Duration: 3 to 4 months
Company: Strata-G

About Us:
At Strata-G, we are committed to driving significant and positive change through the exceptional talent we hire and the impactful solutions we deliver. Our team of engineers, scientists, and business professionals tackles complex energy and environmental challenges across the globe. Our core values—Integrity, Service, Quality, Safety, Innovation, Attitude, and Outreach—guide us in creating a culture of continuous improvement and excellence.

Position Summary:
We are seeking an experienced cGMP Quality Specialist to ensure that radioisotopes intended for use as Active Pharmaceutical Ingredients (API) are produced under the highest standards of quality and control. This role involves interpreting quality assurance requirements, managing production batch records, developing technical documents, and maintaining regulatory filings.

Major Duties & Responsibilities:

Interpret and apply quality assurance requirements as outlined in 21 CFR 211 and ICH Q7 to work procedures and documents.
Review production batch records and grant final approval for the release of radioisotope products.
Assist in developing and implementing technical procedures and quality assurance requirements.
Oversee and evaluate planned change controls for processes, equipment, and facilities.
Maintain current filings with the Food and Drug Administration and other regulatory bodies, including the Drug Master File.
Conduct cGMP training and support the implementation of non-conformance processing.
Build strong relationships with internal and external stakeholders to address issues and ensure customer satisfaction.
Provide guidance for effective management system deployment and review actions related to assessment findings for improvement.
Identify and solve problems to achieve desired business results.

Basic Qualifications:

Bachelor’s degree in Science, Quality Assurance, or a related field.
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.
Ability to obtain and maintain a clearance from the Department of Energy; this includes passing a pre-placement drug test and participating in an ongoing random drug testing program.

Preferred Qualifications:

Strong computer and organizational skills with multitasking abilities.
Excellent oral and written communication skills.
Experience with quality-related aspects of analytical methods (e.g., gamma spectroscopy, inductively coupled plasma spectroscopy).
Background in radioisotope production and environmental controls for manufacturing.
Knowledge of radioactive decay calculations and quality assurance activities, including supporting audits, investigating non-conformances, and implementing corrective actions.
Experience in developing and managing document change control systems.
Demonstrated ability to collaborate effectively with internal and external organizations and provide quality oversight of drug manufacturing.

Job Type:
Contract - 3 to 4 months

Location:
Oak Ridge, TN (Hybrid option available)

Additional Information:
Strata-G does not sponsor applicants for immigrant or non-immigrant work visas. Candidates must provide evidence of identity and employment authorization. Drug tests and background investigations by the Federal government may be required. Strata-G is an Equal Employment Opportunity (EEO) employer, committed to providing equal employment opportunities regardless of race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veteran or disabled status.

Apply Today!
If you are a dedicated and motivated professional with a passion for quality assurance and cGMP standards, we invite you to apply and join our dynamic team at Strata-G.

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Cgmp Quality Specialist

Job Description

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