USA - Quality Associate II

Adecco is currently assisting an American multinational healthcare company in recruiting for a Quality Associate in ROUND LAKE, IL.

Schedule: Full-Time

Pay Rate: The wage for this position is between $30 and $34. Hourly wage may depend upon experience, education, geographic location and other factors.

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.

A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials.

• 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 instrument 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.

**What do we need from you???** ???

• Bachelor's Degree in Science (Chemistry or Biological science) or technical field (Information Technology or Engineering) with 5 or more years' experience, or Master's Degree with 2 or more years' experience.

• 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 off-shift 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, results oriented and task completion.

• Strong Decision-making and technical problem-solving skills.

Click on apply now for instant consideration!

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.

Pay Details: $30.00 to $34.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.