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Quality Assurance Specialist
2 months ago
Job Title: Quality Assurance Specialist - Virology
Assignment Duration: 12 months
Work Schedule: Monday - Friday (standard business hours)
Work Environment: Onsite
Important Note: This position requires a current flu vaccination.
Key ResponsibilitiesThe primary focus of this role involves executing tasks related to method validations and transfers. The specialist will ensure that validation samples are analyzed and assessed in accordance with quality standards, with results documented accurately and in compliance with regulatory and corporate mandates.
Responsibilities include:
- Conducting testing and related activities in accordance with established SOPs and protocols.
- Adhering to policies and procedures to ensure compliance with legal regulations, health and safety standards, and regulatory requirements.
- Developing and maintaining Standard Operating Procedures (SOPs).
- Gaining proficiency in assigned assays and techniques.
- Documenting deviations and invalid assay evaluations.
- Potentially performing shift work to support operational needs.
Educational Background: Bachelor's degree in a scientific discipline with a minimum of 3 years of relevant experience, or an associate's degree with 5+ years of industry experience, or equivalent.
Minimum Qualifications for Level II:
- Bachelor's degree in Biochemistry, Virology, or a related scientific field.
- Experience in maintaining cell lines, cell passaging, or cell counting techniques.
- Some background in an analytical testing laboratory (academic or industry).
- 3+ years of laboratory experience or equivalent.
- Intermediate understanding of GMPs, safety regulations, and data integrity.
- Intermediate knowledge of analytical methods and associated instrumentation.
- Experience with PCR techniques.
Minimum Qualifications for Level I:
- At least 6 months of laboratory experience or equivalent.
- Basic understanding of GMPs, safety regulations, and data integrity.
- Basic knowledge of analytical methods and related instrumentation.
- Some familiarity with PCR techniques.
Common Requirements for Both Levels:
- Bachelor's degree in Biochemistry, Virology, or a related scientific field.
- Experience in maintaining cell lines, cell passaging, or cell counting techniques.
- Some experience in an analytical testing laboratory (academic or industry).
- Current flu vaccination.
Experience in a cGMP Pharmaceutical Laboratory, familiarity with Laboratory Information Management Systems (LIMS), and experience in performing Virus Titer assays, Residual Infectious Virus assays, and other virology-related testing methods are advantageous.
