Quality Associate II

Summary:

Ensure quality assurance oversight and compliance to approved policies and regulations on laboratory computerized systems and instruments that conduct biological chemical and physical analyses on pharmaceutical products through all stages of the manufacturing process from incoming raw materials to finished goods and environmental monitoring programs.

Must not be allergic to Penicillin or Cephalosporin drugs.

Essential Duties and Responsibilities:

Perform administrator functions and maintain user access to laboratory computerized systems and instruments.
Coordinates training with laboratory personnel for computerized systems and instrumentation after updates and enhancements.
Understand and maintain knowledge of sophisticated laboratory instrumentation and computer systems used to collect and record data. Understand and maintain knowledge of advanced laboratory assays requiring precise analytical skills and understanding of scientific principles.
Be a Subject Matter Expert (SME) on computerized systems and equipment and know how to troubleshoot issues with laboratory staff.
Act as a liaison between instrument/plant engineers IT personnel validation and laboratory staff for instrument/system operation.
Provide input and/or review validation protocols related to laboratory instruments and computerized systems. Assess impact of changes to computerized systems and laboratory instruments.
Support projects that involves enhancements or updates to computerized systems or new methods which require instrumentation or systems updates to computerized systems. Complete all activities in a timely and appropriate manner.
Maintain data integrity and ensure compliance with company SOPs and specifications FDA GLP QSR and cGMP regulations. Investigate nonconformance events and write exception documents.
Participate in functions involving teams which impact production increase efficiency solve problems generate cost savings improve quality and provide new product support.
Coordinate with laboratory staff to perform periodic review and laboratory audits. Provide support to audit and update instrument and computerized systems SOPs as required.
Present information and/or respond to questions during compliance audits.

Qualifications:

Prior experience with laboratory information management systems and/or laboratory instrumentation is required.
Experience with BaxLIMS Empower CDS LabVantage Electronic Lab Notebook (ELN) Bacterial Endotoxin Readers highly desired.
Strong knowledge of FDA ISO and GMP regulations.
Ability to communicate between various levels of engineering validation IT and laboratory personnel.
Ability to handle multiple tasks concurrently and in a timely fashion. Occasional offshift or weekend work may be required.
Must be able to communicate effectively with managers peers and subordinates.
Strong leadership organization and time management skills and ability to manage multiple tasks.
Must demonstrate effectiveness in ability to train others empowerment resultsoriented and task completion.
Strong Decisionmaking and technical problemsolving skills.
Physical demands of the position may require the ability to lift materials or equipment up to 50 lbs. and wear personal protective equipment.


Education and/or Experience:

Bachelors Degree in Science (Chemistry or Biological science) or technical field (Information Technology or Engineering) with 5 or more years experience or Masters Degree with 2 or more years experience.