Quality Control Analyst
475 Green Oaks Parkway Holly Springs, NC 27540 US
Job Description
*Depending on experience
Job Description:
Primary responsibilities for this position include performing tasks associated with method validations and transfers.
The analyst will be responsible for ensuring that Seqirus validation samples are tested and reviewed according to quality requirements and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements.
Analyst may be required to perform or participate in tasks associated with method validation and transfers.
• Performs testing and associated tasks without errors per applicable SOPs and protocols.
• Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
• Develops and maintains SOPs
• Develops expertise in assigned assays/techniques
• Authors deviation and invalid assay assessments
• May be required to perform shift work as required to support the operations Ideal Background Education Bachelor’s degree in Scientific discipline and 3+ years’ experience or associate’s and 5+ years of industry experience or equivalent
Minimum Required Qualifications:
• BS/BA in Biochemistry, Virology, or other related science field
• Experience with maintaining cell lines, cell passaging, or cell counting techniques
• Some experience with working in an analytical testing lab (academic or industry)
• 3+ years of laboratory experience OR equivalent
• Intermediate knowledge of GMPs, safety regulations and data integrity
• Intermediate knowledge of analytical methods and related instrumentation
• Experience performing PCR
Preferred / Nice to Have Qualifications:
• Experience working in a cGMP Pharmaceutical Laboratory
• Experience with Laboratory Information Management Systems (LIMS)
• Experience performing Virus Titer assays, Residual Infectious Virus assays and other virology-based testing methods
Does this role require PPE (not otherwise provided): yes, safety shoes are required
Reason for request (backfill, etc): backfill
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