DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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For further inquiries regarding the following opportunity, please contact one of our Talent Specialist
Dipankar
Title: Compliance Engineer
Location: Round Lake, IL
Duration: 5 months (Possibility for extension)
100% Onsite
Day shift with minimal possibility of overtime
Candidates cannot be allergic to Penicillin or Cephalosporins.
Description JOB SUMMARY: Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System. Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements. Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned: -Work with internal auditors to develop programs to ensure continued compliance with policies and regulations.
-Support internal audit process ensuring compliance with all applicable regulations and standards.
-Evaluate quality data and determine strategies, actions, and initiatives to drive improvements in the facility. Work with cross functional teams on implementation.
-Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness.
-Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure.
-Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes.
-Performs follow-up audits, when applicable, to confirm corrective and preventive action is effective.
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 regulatory experience is a plus.
Experience
-Knowledge of drug manufacturing background and FDA regulations is a must.
-It is essential to have audit experience in a lab and manufacturing environment. This position will involve coaching other SMEs during audits.
-Good knowledge of lab, manufacturing facilities, USDA, and FDA guidelines is required.
-Someone who has previously worked as an FDA inspector, GMP auditor, or compliance auditor is preferred.
-A quality background in a pharma environment is desired.
-Good communication skills are required as this role will involve interacting with senior leadership frequently.
-Very minimal to zero hands-on work, mostly supporting audits and training and coaching other auditors.
Only two rounds - phone interview followed by onsite/virtual interview
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.