5938 QC Analyst I
Description:
QC Analyst in QC Microbiology.
Responsible for sampling and testing of utility systems and manufacturing process spaces.
Perform routine and non-routine sample collection according to cGMPs.
Perform a broad variety of basic to complex sample collection and tests in support of lab operations.
Perform assays/laboratory maintenance functions.
Prepare basic and complex laboratory reagents.
Perform data verification and review against established acceptance criteria.
Identify and initiate discrepancies and evaluate the cause.
Understand the theory of assays; use SOPs, validation protocols, specifications, trends, and expertise to propose solutions to assay issues.
Coaching others in assay/laboratory functions using technical expertise.
Order and maintain a lab supply inventory.
Identify assay anomalies.
Anticipate problems and notify the supervisor.
Identify problems and propose solutions to systems, procedures, and training materials.
Understanding/knowledge of QC Microbiology systems.
Assume responsibility for training and communication of issues.
Understanding of and adherence to global systems and GMP Compliance requirements/regulations.
Assist in preparing for internal and external inspections by ensuring the laboratory is inspection ready at all times.
Coordinate with customers to support operational activities.
Perform other duties as requested by supervisor/manager to support Quality.
Skills:
Strong verbal and written communication skills, ability to organize and present information both formally and informally.
Ability to create an environment of strong team spirit and diversity.
Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
Routinely exercises sound judgment, reasoning, and problem-solving.
Capable of working under moderate supervision, independently and as a team, and determining own short-term priorities.
Develop the ability to influence using technical and personal reasoning.
Capable of completing assigned responsibilities and keeping supervisor informed.
Capable of lifting up to 30lbs (on flat ground and up stairs) and standing for prolonged periods of time.
Able to work in process space areas requiring gowning and mask as well as pass vision screening.
Able to work in a laboratory environment in the presence of hazardous materials.
Able to use stairs, ladders, stoop, bend, and kneel as required for gowning and sampling procedures.
Must be able to work Day and/or Swing Shift and weekends.
Education:
B.S./B.A degree.
0-3 years of experience or an equivalent combination of education and experience.
Degrees are preferably in relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry.
Experience with classified cleanroom gowning and utility systems.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.