Duration: 12 months contract

Shift Details: USA-1

Job Description:

Compliance Compliance & Improvement Engineer

Candidates cannot be allergic to Penicillin or Cephalosporins.

Description
JOB SUMMARY: Design, develop, integrate, test, evaluate or improve integrated systems or related processes, primarily with human factors, quality control, inventory control, and material flow, cost analysis, and production coordination. Must work with manufacturing personnel, quality, labs, supply chain, and site leadership to improve the quality and efficiency of processes, increase productivity and decrease costs. Must be able to evaluate quality data and develop programs and initiatives to ensure continued compliance to regulations and standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Other duties may be assigned:
-Take ownership of the management of SLT GEMBA process execution and subsequent action items, create communication and training materials for site operations personnel, Identify opportunities or implement changes to improve products or reduce costs. Drive site implementation of 65S with OpEx leaders
-Work with internal auditors to develop programs to ensure continued compliance with policies and regulations.
-Evaluate quality data and determine strategies, actions, and initiatives to drive improvements in the facility. Work with cross functional teams on implementation.
-Troubleshoot new or existing product problems involving human factors, materials, or processes. Provide technical expertise or support related to manufacturing.
-Confer with engineers or other personnel to implement operating procedures, resolve system malfunctions, or provide technical information.
-Determine root causes of failures using statistical methods and recommend changes in designs, tolerances, or processing methods.
-Perform nonconforming material analysis and create NCM reports. Work with Quality Control on reducing the NCMRs. -Plan and establish sequence of operations to fabricate and assemble parts or products and to promote efficient utilization.
-Read and interpret blueprints, technical drawings, schematics, or computer-generated reports. -Update documentation for job instructions, work instructions, and standard operating procedures. -Ensure safety procedures are followed, work areas are clean and maintained, and the department is following regulatory compliance requirements.
-Evaluate precision and accuracy of production and testing equipment and engineering drawings to formulate corrective action plan.
-Recommend design modifications to eliminate machine or system malfunctions.
-Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness.
-Supervise the work of technicians and other associates as needed.
-Guide technical staff engaged in developing materials for specific uses in projected products or devices.

Qualifications:

• Knowledge of cGMP and global regulatory guidelines such as EMA, FDA, and other health agencies.
• Knowledge of Six Sigma methodology and LEAN principles.
• Effective communicator at all levels; excellent written, oral, and interpersonal communication and presentation skills
• Experience with pharmaceutical and/or device quality and compliance management systems, desired.
• Hands-on experience in drug product aseptic manufacturing operations is desired, but not required.

Education and Experience
•At least 5 years of directly related experience within the pharmaceutical industry or medical device experience
•BS in Science or Engineering. Advanced degree a plus.
•Project management experience, preferred.
•Previous experience with due diligence, auditing, compliance management, or post-acquisition quality systems integration a plus

#IND2

Job Type: Contract

Pay: $60.00 - $64.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Round Lake, IL 60073: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Please confirm your Email address:
• Are you okay with the given pay rate?

Education:

• Bachelor's (Preferred)

Experience:

• the pharmaceutical industry or medical device: 5 years (Preferred)
• Project management: 1 year (Preferred)
• Six Sigma methodology and LEAN principles: 1 year (Preferred)
• cGMP and global regulatory guidelines such as EMA, FDA: 1 year (Preferred)

Work Location: One location

edictplatform.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, edictplatform.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, edictplatform.com is the ideal place to find your next job.