Responsible for compliance audits and quality systems assessments thereby ensuring compliance with all applicable processes, systems and provisions of the Quality System (including regulatory requirements of the intended country of sale). Conducts assessments of various operations within the Cherry Hill plant to ensure compliance with applicable company procedures, applicable country regulations, directives, standards, inspection guidelines, and compendia. Performs audits of Suppliers and CMOs to ensure compliance with applicable regulations.

• Prepare yearly internal and external audit schedules and adhere to the schedules.
• Prepare for the audit/assessment activity by researching background information, including previous audit results.
• Assist in planning and developing assessment strategies and logistics.
• Perform the audits / assessments of the Cherry Hill site, suppliers, and CMOs by collecting and analyzing objective evidence regarding issues and risks. This will include occasional auditing during off-shift hours and approximately 25% travel.
• Summarize the findings and communicate to management.
• Ensure timely receipt of responses from all applicable departments, suppliers, and CMOs.
• Evaluate corrective and preventive action responses to the assessment findings for adequacy, appropriate root cause, and timeliness.
• Elevate issues to management, as appropriate.
• Maintain the assessment files through the process to closure.
• Report extended corrective actions to management.
• Perform follow-up audits to confirm corrective and preventive actions are effective.
• Prepare monthly reports, quality scorecards, and trending charts.
• Remain current in regulatory trends through attendance at related conferences, seminars, meetings and other training methods such as independent study of periodicals, Internet or other literature.
• Maintain the internal audit CAPA database.
• Evaluate and enhance audit procedures to ensure compliance with cGMPs /Regulatory requirements and company policies.
• Participate and assist in regulatory and client audits.
• Handle special projects that are assigned by management.

BS degree in chemistry, biology, pharmacy or related scientific discipline is required. In lieu of a degree in a scientific discipline, a BS degree along with experience in a pharmaceutical manufacturing environment or highly regulated industry may be considered.

• Previous auditing experience
• 5 years of pharmaceutical industry experience in QC/QA
• ASQ and /or RAB auditor accreditation preferred
• Must have sound judgment and analytical skills to enable assessment of risk
• Resourceful, self-reliant, self-motivated and confident
• Strong understanding of cGMPs and regulatory requirements, company procedures and policies
• Excellent interpersonal, communication and technical writing skills
• Knowledge of computer programs such as Word, Excel, Access, Power Point, Statistical software, TrackWise®

• Sign-On Bonus terms:

Bonus offered for a limited time and only applies to individuals with a start date occurring between November 29, 2021 and March 1, 2022

Additional terms and conditions apply

WWHIGH