Compliance Officer

4 weeks ago

Bristol, Virginia, United States Jackson Healthcare Full time
Job Description

At Jackson Healthcare, we are seeking a highly skilled Compliance Officer - Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the adherence of company policies and procedures, especially regulatory and ethical standards as governed by state, local, federal and international pharmaceutical regulatory agencies.

Key Responsibilities:

  • Coordinate and participate in quality audits of other departments within the organization for compliance with cGMPs and company policies and procedures.
  • Support the QC laboratories and Technical Services in compliance with cGMP standards, registered details, and product specifications and release criteria.
  • Prepare preliminary documentation (i.e., technical writing) for investigations, SOPs, change controls, CAPAs, regulatory submission content, and other Quality Assurance related documentation.
  • Complete periodic Standard Operating Procedure (SOP) reviews for Quality unit and notify management of any SOPs that may require revision.
  • Responsible for issuance and maintenance of cGMP procedures to include cGMP documentation maintenance, storage, and archival process.
  • Perform batch record review and release for product distribution.
  • Support preparation of Annual Product Review and Annual Reports.
  • Utilizing advanced knowledge of FDA regulations and principles, compile trending quality data reports for management review.
  • Investigate root cause(s) and develop appropriate Corrective and Preventive Actions (CAPAs) for plant incidents.
  • Responsible for guiding other departments with Change Controls, Corrective and Preventive Actions (CAPA), Master Batch Record (MBRs) review, and other Chemistry, Manufacturing and Control (CMC) changes.
  • Responsible for full-cycle Product Complaint process and initiate steps required to close these investigations.
  • Under the direction of the department director, identify and implement quality system improvements, including training programs and assisting site with FDA preparedness activities.

Requirements:

  • Bachelor's degree in Chemistry or related science from an accredited institution.
  • Minimum five (5) years of analytical experience in pharmaceutical industry or related technical scientific work experience.
  • Knowledge and experience of cGMPs and regulatory documentation.
  • SAP experience a plus. Quality certifications and Operational Excellence experience desired and statistical experience a plus.

Skills and Abilities:

  • Demonstrates comprehensive understanding of Title 21 CFR Part 210 and 211 and applicable compendial requirements and scientific concepts in decision making.
  • Knowledge and understanding of pharmaceutical QC analytical techniques and test methodologies, production processes, and reporting for data integrity and compliance with procedures, product registrations, and cGMPs.
  • Experience with the concepts and validation methods, processes, equipment, facility, utilities, computerized software.
  • Strong knowledge of cGMPs, USP and FDA's related requirements.
  • Strong verbal communication skills and technical writing skills.
  • Provides technical expertise, risk assessments and solutions related to possible compliance, technical, or safety-related issues and notifying management promptly.
  • Advanced computer skills.
  • Ability to prioritize multiple and competing projects and decide appropriate course of actions routinely.
  • Ability to work in a cross-functional team environment with a flexible, team-oriented perspective.
  • Appropriate interpersonal (teamwork) and leadership skills.
  • Self-motivated and able to execute decisions timely and effectively.

Language: English

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