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Quality Control Analyst
1 month ago
Length of Assignment: 12 months
Shift/Schedule Details: Monday - Friday (standard business hours)
Location: Holly Springs, NC (no remote; 100% onsite)
IMPORTANT PLEASE NOTE - This role requires a current flu vaccine.
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.
Analysts 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 for Level II:
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
Minimum Required Qualifications for Level I:
6 months or more laboratory experience OR equivalent
Basic knowledge of GMPs, safety regulations and data integrity
Basic knowledge of analytical methods and related instrumentation
Some knowledge of performing PCR
Required for BOTH Level I and Level II:
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)
Current flu vaccine
Preferred / Nice to Have Qualifications for either Level:
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 by CSL): yes, safety shoes are required
