Compliance Officer (Inspection Coordinator)

About the role

Responsible for implementing and maintaining a functional internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards.

Responsibilities

• *Responsible for Regulatory Compliance at the plant level which includes planning and conducting internal compliance audits of all operations within the facility.
• *Serve as plant administrator for all company and regulatory agency (i.e. DEA, FDA) inspections.
• *Convey all violations to appropriate plant management/supervisory personnel via written reports and/or open discussions in audit wrap-up meetings.
• *Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• *Keep current with all regulatory requirements and disseminate and interpret all regulatory requirements to plant personnel in a timely and accurate fashion.
• *Consult with plant personnel on regulatory requirements and compliance related topics.
• *Responsible for management review and associated metrics for the plant
• *Administrate/coordinate the plant manufacturing materials and pest control programs.
• *Coordinate and facilitate major plant quality improvement projects at the plant or company level.
• *Perform process of metrics collection and analysis for compliance-related corrective and preventive actions (CAPA's)

Qualifications & Requirements

• *Bachelor's Degree, preferably in Science or Engineering, or equivalent related work experience is required.
• *3+ years of Biopharmaceutical experience
• *Quality Assurance/Regulatory Affairs/Compliance experience required
• *Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA).
• *Able to demonstrate extensive knowledge of plant and company level procedures.
• *Ability to evaluate quality, production and support areas for compliance to GMPs. BOPs, etc.
• *Strong decision making
• *Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.