QC Analyst

1w1 week ago

CSL

Holly Springs, US · Full-time · $55,000 – $75,000

About this role

Seqirus offers an exciting opportunity to join the expanding team in Holly Springs, NC, at an advanced manufacturing facility. As a world leader in influenza vaccine production, the company draws expert staff from different countries to collaborate globally. Join a team dedicated to protecting communities from seasonal influenza and pandemic threats.

Primary responsibilities include performing tasks associated with release testing and reviewing laboratory data within the QC Microbiology department. Ensure CSL Seqirus samples are collected, tested, and reviewed according to quality requirements. Confirm results are valid, accurate, and documented per applicable regulatory and corporate requirements.

Operate in a lean lab with 6S layout, participating in preventive action and continuous improvement programs to reduce costs. Perform shiftwork as necessary, including Wednesday to Saturday 10-hour days, and cross-train within the QC department. Comply with policies to maintain legal, health, safety, and regulatory standards.

Develop and maintain SOPs while building expertise in assigned assays and techniques. Author deviation and invalid assay assessments to support operations. Experience a feeling of possibility, creativity, and purpose in making a difference in people's lives.

Requirements

Bachelor's degree in Microbiology, Biology, Biochemistry, or equivalent preferred
Minimum of 1-5 years of laboratory experience OR equivalent
One year of GMP, safety regulation and data integrity experience preferred
Knowledge and/or experience performing microbiology assays; endotoxin, bioburden, and sterility preferred
Knowledge of analytical methods and related instrumentation
Knowledge of aseptic technique and environmental monitoring procedures/practices (air, surface, personnel, and water)
LIMS experience preferred

Responsibilities

Perform testing and associated tasks without errors per applicable SOPs and protocols
Comply with policies and procedures to maintain compliance with legal regulations, health and safety, and regulatory requirements
Participate in lean lab operation, 6S laboratory layout, preventive action and continuous improvement programs
Perform shiftwork as necessary to support manufacturing
Participate and perform in cross-training to support staff availability within QC department
Develop and maintain SOPs
Develop expertise in assigned assays/techniques
Author deviation and invalid assay assessments

Benefits

Join a global company working on the front line to protect communities from influenza
Part of CSL Seqirus, a major contributor to influenza prevention with facilities in U.S., U.K., and Australia
Inclusion and belonging at the core of the mission, fueling innovation