Change Control Compliance Specialist

4 weeks ago

Greenville, United States PAI Holdings LLC Full time
Job DescriptionJob Description

JOB SUMMRY:

This position ensures quality and compliance to cGMPs, internal, external and international requirements with respect to change control activities. Responsibilities include day-to-day quality assurance review and approval of change proposals, prior to initiations into the workflow process. This position facilitates cross functional workflow activities and provides guidance and consultation to change proposal owners. Maintains change control procedures and makes recommendations to continuously improve processes and provides an overall understanding of the impact of changes made in an integrated pharmaceutical system.

Coordinator will assume charge of change control activities to coordinate activities related to the initiation, review, approval and closure of changes and maintain pertinent electronic databases accordingly for all cGMP documentation. The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  1. Manage the Change Control Program related to the change initiations, reviews, approvals and closure of changes.
  2. Creates and maintains pertinent electronic databases for the change activities accordingly for all cGMP documentation, to include open, extended, closed and canceled tracking of change submissions.
  3. Manges the Change Control system with the receipt of change control requests, assigning of change control numbers, assisting with initial quality assurance assessments, emailing status update links to personnel, and maintaining of the status log.
  4. Manages day-to-day activities to ensure changes are being proposed are properly documented, planned, coordinated and implemented within PAI’s policies and procedures.
  5. Enforces technical review processes and procedures to ensure changes are communicated to all affected parties.
  6. Performs edits and compliance checks of documents and change control records.
  7. Maintains electronic filing, scanning, maintenance, and organization of controlled documents
  8. Provides continuous training for end users as it applies to creation and management of change request.
  9. Maintains electronic database for tracking of change request for review, signatory and implementation of changes.
  10. Identifies document discrepancies and provides quality control/quality assurances to revisions and document releases for control purposes. Provides assistance with formatting of documentation.
  11. Manages the electronic master file with insertion of approved documentation or removal of obsolete/inactive documents.
  12. Reviews updates of Manufacturing and Packaging Batch Records, Packaging Specifications and Instructions, Component/Container/Closure Specifications, and Component Purchasing Specifications and initiate the approval flow for the documents.
  13. Provides backup for batch record issuance, standard operating procedures and work instructions, destruction of materials, and log books as needed.
  14. Establishes and maintains effective working relationships with managers and employees and the ability to mentor individuals of various levels within the organization to gain understanding and/or acceptance of an idea, policy, procedure or plan that obtains to quality principles.
  15. Supports audits, maintains quality metrics and provides assistance to the organization as applicable.

EDUCATION AND/OR EXPERIENCE:

Bachelors’ degree or equivalent years of experience, preferably in the Pharmaceutical industry. Microsoft suite software is required, knowledge of electronic document/training systems and GMP documentation is preferred.

KNOWLEDGE, SKILLS & ABILITIES:

Strong oral and written communication skills, good analytical ability and problem-solving skills. Critical thinking application, Attentiveness to details and deadlines with the ability to prioritize work effectively. Flexibility to operate, and self-driven to excel, in a fast-paced environment. Demonstrate ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a proven ability to shift thought processes quickly from one task to another. Strong Microsoft skill set, to include documentation formatting, Adobe application an Signature workflow process.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Computer keyboarding, computer monitor and mouse use including reaching forward, grasping, finger and wrist manipulations, and neck bending and turning: near vision is necessary for computer monitor use. Frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands.

PAI is an Equal Opportunity Employer. PAI uses E-Verify.

EEO Employer / Veteran / Disabled.

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