Pharmaceutical Quality Compliance Data Integrity Steward II

Position Summary:

The Data Steward II position at CAPS is responsible for implementing and continuously improving the Site Data Integrity Program. This role requires maintaining a comprehensive knowledge of data integrity quality and regulatory requirements, identifying compliance risks, and developing solutions to address those gaps. The Data Steward will coordinate the quality, security, and maintenance of data to ensure compliance and support business processes effectively.

*Quality Assurance department

Responsibilities: Essential Duties

• Implement and continuously improve the Site Data Integrity Program.
• Maintain knowledge of applicable data integrity quality and regulatory requirements.
• Identify data integrity compliance risks and gaps across the site.
• Communicate risks to Site Management and develop solutions to address gaps.
• Coordinate the quality, security, and maintenance of data.
• Create data process mapping and risk reduction efforts for data owners and Quality representatives.
• Define data elements and establish policies and procedures related to data collection and accuracy.
• Perform tests and audits on data systems to ensure data quality.
• Create methodologies and metrics for tracking performance to Data Integrity expectations.
• Act as system administrator for manufacturing and laboratory systems.
• Support implementation of electronic software and systems.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

General:It shall be the duty of every employee while at work to take reasonable care for safety and health ofhimself/herself and other persons.

Expertise: Knowledge & Skills

• Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
• Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.
• Judgement is required in resolving complex problems based on experience.
• Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required.
• 04-06 years related experience required.
• Occasional business travel required, Valid driver's license and passport

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

Responsibilities: Other Duties:

The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

Physical Demands:

While performing the duties of this job, the employee is expected to:

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

• Occasionally:Reaching upward and downward, Push/pull, Stand
• Frequently:Stand,Sit
• Constantly:N/A

Activities:

• Occasionally: Push/pull, Reaching upward and downward, Standing, Walking
• Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick
• Constantly:N/A

Environmental Conditions:

• Occasionally:N/A
• Frequently:N/A
• Constantly:N/A

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Noise Intensity: Low
• Occasionally: Production/manufacturing environment
• Frequently:N/A
• Constantly:Office environment

Base Salary: $95,615 - $120,096

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