Experience Inc. Jobs

Senior Compliance Analyst

Location:Deerfield, IL, United States

Job Type:Contract

Job Category:Pharmaceutical and Biotech

Job Industry:Pharmaceuticals and Medical Products

Salary:The pay we're offering is $40 - $50 per hour

Description

We're looking for aSenior Compliance Analyst, working inPharmaceuticals and Medical Productsindustry in1 Takeda Parkway, Deerfield, Illinois, 60015, United States.

Job description:

• Accountable for investigating non-medical product complaints involving commercial products, ensuring the thoroughness and timeliness of these investigations.

• Accountable for the accurate and timely trending (statistical and practical) of non-medical commercial product complaints and for timely communication of any data trends/issues to management as appropriate.

• Responsible for liaising with third parry manufacturers/packagers to ensure thorough, accurate and timely complaint investigations.

• Responsible for posting complaint data to the Sharepoint site in a timely manner.

• Responsible for facilitating the investigation process (coordinating the gathering of external information, identifying cross-functional team members, facilitating team meetings, and assuring adequacy of supportive documentation) to ensure that Quality Assurance investigations for non-medical commercial complaints and complaint trends effectively identify issues, and that underlying systemic problems are adequately addressed to prevent future recurrence.

Our Client

Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.

Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.

Experience Required for Your Success

Requirements:

• Bachelors degree in science or pertinent technical field required

• Minimum 4 years QA or related experience in a cGMP regulated environment

• Minimum 3 years experience in pharmaceutical industry environment

• Minimum 3 years experience in managing non-medical product complaints

• Experience with supplier management, plant operations, metrics concepts, statistical process control and other quality engineering tools required

• Minimum 3 years experience with direct customer interaction.

• Knowledge of cGMP regulations governing: drug development and manufacturing, analytical laboratory processes, packaging and labeling activities, distribution and returned goods preferred

• Knowledge of project management, CAPA handling, quality systems, investigation follow up and processing quality documentation systems desired

• Strong oral/written communication skills

• Knowledge and ability to utilize Microsoft Word, Excel, Access, and PowerPoint programs required

• ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) desirable

• Project Management certification desirable

• Experience with Citrix/Siebel based programs

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required

• Requires approximately 5% travel

What Do You Think?

Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?