Title -- Compliance Engineer Duration – 06 Months Location – Round Lake, IL (60073) Must not be allergic to Penicillin or Cephalosporins.
Description 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: -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.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $53.00/hr.
