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Quality Assurance Specialist
2 months ago
Position Overview
Location: 100% ONSITE
Contract Duration: 1 year
Target Pay Rate: $24-28
Work Schedule: Monday - Friday (standard business hours)
Note: A current flu vaccination is mandatory for this role.
Job Responsibilities:
The primary focus of this role is to conduct tasks related to method validations and transfers.
The Quality Analyst will ensure that validation samples are tested and assessed in accordance with quality standards, with results being reported accurately and documented in compliance with relevant regulatory and corporate guidelines.
Key responsibilities include:
- Executing testing and related tasks flawlessly in accordance with established SOPs and protocols.
- Adhering to policies and procedures to maintain compliance with legal regulations, health and safety standards, and regulatory requirements.
- Creating and updating Standard Operating Procedures (SOPs).
- Gaining proficiency in assigned assays and techniques.
- Documenting deviations and invalid assay evaluations.
- Potentially working shifts as necessary to support operational needs.
Minimum Qualifications for Level II:
- 3+ years of laboratory experience or equivalent.
- Intermediate understanding of Good Manufacturing Practices (GMPs), safety regulations, and data integrity.
- Intermediate knowledge of analytical methods and associated instrumentation.
- Experience with Polymerase Chain Reaction (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 discipline.
- Experience in maintaining cell lines, performing cell passaging, or cell counting techniques.
- Some background in working within an analytical testing laboratory (academic or industry).
- Current flu vaccination.
Preferred Qualifications:
- Experience in a cGMP Pharmaceutical Laboratory.
- Familiarity with Laboratory Information Management Systems (LIMS).
- Experience conducting Virus Titer assays, Residual Infectious Virus assays, and other virology-related testing methods.
Additional Information:
Personal Protective Equipment (PPE) is required for this role; safety shoes must be worn.
This position is intended to cover for holiday or leave of absence.
