4449 Sr QC Analyst
Conducts routine and non-routine laboratory equipment maintenance.
Performs sample management maintenance including but not limited to raw materials, in-process items, finished product and stability program according to established operating procedures.
Revises and updates standard operating procedures as needed.
May perform special projects on analytical and instrument problem solving.
Participates in the preparation of investigations, summaries and reports.
Perform routine and semi-routine assignments that are complex in support of lab operations:
Perform maintenance on Laboratory equipment in support of laboratory operations.
Exhibit detail oriented documentation skills to ensure Right-First-Time operations.
Identify and support resolution of technical problems.
Coordinate with customers to support operation activities.
Prepare basic and complex reagents as assigned.
Create and maintain finite schedules.
Create and maintain work in progress tracking tool.
Receive and provide training.
Identify discrepancies, participate in quality investigations and CAPA (corrective actions
preventive actions) initiative as needed.
Actively participate in group and project teamwork; project and process improvement.
Good understanding of global systems and cGMP Compliance requirements/regulations.
Assist in preparing for internal and external inspections by ensure Laboratory is inspection ready
at all times.
Ability to create/revise lab associated documents e.g. testing procedures, FNs, SOPs.
Perform other duties as requested by managers to support Quality activities.
B.S./B.A degree, or 2-3 year experience in the related industry, or an equivalent, combination of education and experience.
Knowledge of cGMP or equivalent regulations.
Strong verbal and written communication skills, ability to organize and present information both
formally and informally.
Capable of completing assigned responsibilities and keeping management informed of status.
Routinely exercises sound judgement, reasoning, and problem solving.
Ability to work under minimal supervision to complete assigned tasks in a timely manner.
Takes responsibility, drives results, and achieve expected outcomes.
Experience with SAP.
Work Environment/Physical Demands/Safety Considerations
Prolonged periods of standing at laboratory bench top.
Frequent lifting (up to 20 lbs.), bending, reaching, twisting.
Use of step ladders and push carts required.
Ability to work off shifts and/or weekends