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Actively monitors the organization’s compliance with the laws and regulations using an auditing program and other oversight activities and conducts investigations where non compliance may exist and reported.

Essential Duties:

• Coordinate applicable policies and procedures and employee training on compliance.
• Assures the compliance program effectively prevents and/or detects violations of regulations and/or company policies/procedures.
• Communicates to all employees on compliance program’s expectations and responsibilities.
• Assist in facilitating and coordinating all investigations related to CAPA and Customer Complaints and track the status of all reports and investigations.
• Plan and conduct internal audits.
• Write audit reports and track responses, conduct follow-up evaluations of

• Assist in scheduling and participating in external vendor audits of suppliers, contract manufacturers, laboratories and other service providers to ensure compliance with c GMP, ICH, Part 11 and other regulatory requirements.
• Develop and implement corrective/preventative action plans resulting from noncompliance investigations.
• Participate in regulatory inspections and inspection readiness activities.
• Engage in open communication with, and provide reports to the management review committee.
• Updates policies and procedures as necessary.
• Develop SOPs for functional areas and related training.
• Participate in compliance improvement initiatives, as required.
• Provide Quality Metrics and coordinate periodic reviews to inform management

• Assist with other projects as needed.

Qualifications and Experience:

• Desired, but not mandatory, a BS in Chemistry / Biology or scientific discipline.
• Minimum 1-3 years compliance experience.
• Experience and understanding of FDA regulations desired.
• Knowledge and understanding of c GMP and Part 11 regulations.
• Auditing experience desired.
• Proficient in MS Office applications.
• Competence concerning c GMP requirements/regulations.
• Excellent communication (both verbal and written) and listening skills.
• Perseverance in investigating alleged noncompliance.
• Ability to analyze information and critical thinking.
• Attention to detail, good follow-through, sound organizational and time

• Strong analytical and problem-solving skills.
• Must be able to work collaboratively across departments and with external

vendors and contractors.

Work Environment:

• Office setting
• Production environment when auditing.
• Appropriate personnel protective equipment (when necessary).

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 10 hour shift
• Day shift

Application Question(s):

• Do you require sponsorship or continued sponsorship to work in the United States?
• The compensation range for this position is $23.32 per hour to 28.85 per hour. What are your compensation expectations?

Ability to Relocate:

• Elgin, IL 60123: Relocate before starting work (Required)

Work Location: In person