What are the responsibilities and job description for the Change Control Compliance Specialist position at Pharmaceutical Associates?
Job Summary
The Change Control Compliance Specialist serves as a Subject Matter Expert (SME) and Owner in the performance and management of the Quality Systems Change Control Program. As the Change Control Compliance Specialist, you will prepare change control documents and be coordinating change control activities from initiation through completion / implementation as defined in the change control requirements. You will also be the primary individual performing status update of changes in the TrackWise change control system, including closure of change control documents. This role reports to the Quality Technical Director.
Essential Duties and Responsibilities :
- Manage the Change Control Program related to the change initiations, reviews, approvals and closure of changes.
- 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.
- Manage performance of change control as measured by the measurements.
- Interface with TrackWise for coordination of change control documents and status updates.
- 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.
- Track Metrics tied to Change Management and provide updates for department management monthly
- Perform documentation / formatting changes (SOP's, batch records, PM's, BOM's, product specifications) or create new documents.
- Lead teams, encourage teamwork, and make sound assigned decisions (e.g. technical, compliance, and operations).
- Analyze change control process and responsibilities to identify opportunities for continuous improvement.
- Reduce the cost of non-value-added activities and developing strategies to achieve department goals.
- Maintain data integrity and ensure compliance with company SOP's and specifications, FDA, and cGMP regulations.
- Perform other support activities as needed.
EDUCATION AND / OR EXPERIENCE :
Bachelor's degree in a relevant field such as Life Sciences, Chemistry, or Engineering preferred. In lieu of science based degree, a combination of Bachelor's degree and 5 years' pharmaceutical experience will be considered.
Minimum of 3-5 years of experience in Quality Assurance within the pharmaceutical industry. Change Management experience preferred. Microsoft suite software is required, knowledge of electronic document / training systems and GMP documentation is preferred.
KNOWLEDGE, SKILLS & ABILITIES
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.