QC Analyst II, Chemistry

Job Title: QC Analyst II, Chemistry
Work Location Holly Springs, NC
Contract duration: 06
Job Id: 8190421
Job Purpose
Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data. Secondary responsibilities include cross training of staff. The analyst will be responsible for ensuring that Seqirus Vaccines samples are collected, 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.

Major Accountabilities
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.
Participates in lean lab operation, 6S laboratory layout, KATA, preventive action & continuous improvement programs to reduce operating costs
Performs shift-work as necessary to support manufacturing
Participates and performs in cross-training to support staff availability within QC department
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 operations

Skills:
3+ years minimum of laboratory experience OR equivalent
Intermediate knowledge of GMPs, safety regulations and data integrity
Intermediate knowledge of analytical methods and related instrumentation.
LIMS experience preferred

Keywords:
Education: Bachelor's degree in Scientific discipline and 3+ years' experience or associate's and 5+ years of industry experience or equivalent