Senior Change Control Specialist

JOB SUMMRY:

This position ensures leadership and mentorship for quality and compliance to cGMPs, internal, external and FDA as well as ICH 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.  Assure whether a change is local or global.  This position facilitates cross functional workflow activities and provides guidance and consultation to change proposal owners.  Approves change plan/task activities for each overarching product change.  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. 

The Change Control specialist will be a coordinator to assume charge of change control activities to coordinate activities related to the initiation, oversight, review, change plan assessment, 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 accommodation 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, assessments, change plan creation, 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, extension, review, risk assessment, closed and canceled tracking of change submissions.

3.    Manages the Change Control system with the receipt of change control requests, assigning of change control numbers, determination of global or local change, assisting with initial quality assurance assessments, emailing status update links to personnel, and maintaining of the status log in the electronic system.

4.    Manages day-to-day activities to ensure changes are being proposed are properly documented, planned, actions or tasks are defined with completion dates, 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 actions, risk assessment, and documentation or 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 and completion.  

9.    Maintains electronic database for tracking product changes 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.  

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.  Aids in moving this activity to the Document Control system.

13.    Provides backup for batch record issuance, standard operating procedures and work instructions, destruction of materials, and logbooks as needed.

14.    Establishes and maintains effective working cross-functional 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.

EDUCATION AND/OR EXPERIENCE:

Bachelors’ degree or equivalent years of experience, preferably in Pharmacy, Chemistry, Biology, Engineering or a related field.  Knowledge of systems and processes which support Quality Management System. Specifically, operational experience in the core QMS processes such as quality change control and CAPA eQMS.  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 accommodation may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.  Computer keyboarding, computer monitor and mouse use include reaching forward, grasping, finger and wrist manipulation, 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.