B. Braun Melsungen AG
Pharmaceutical Quality Compliance Data Integrity Steward II
B. Braun Melsungen AG, Phoenix, Arizona, United States, 85003
Pharmaceutical Quality Compliance Data Integrity Steward II Job Description
You’re an important part of our future. Hopefully, we’re also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
Company: Central Admixture Pharmacy. Location: Phoenix, Arizona, United States. Functional Area: Quality. Working Model: Onsite. Shift: 5X8. Relocation Available: Yes.
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
CAPS®, part of the B. Braun Group of Companies in the U.S., is the nation’s largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation’s largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
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.
Responsibilities
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.
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.
Target salary range is $98,783-$110,000/yr + benefits + bonus.
Schedule: Monday - Friday 8am-5pm.
Physical Demands
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.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .
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You’re an important part of our future. Hopefully, we’re also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
Company: Central Admixture Pharmacy. Location: Phoenix, Arizona, United States. Functional Area: Quality. Working Model: Onsite. Shift: 5X8. Relocation Available: Yes.
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
CAPS®, part of the B. Braun Group of Companies in the U.S., is the nation’s largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation’s largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
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.
Responsibilities
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.
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.
Target salary range is $98,783-$110,000/yr + benefits + bonus.
Schedule: Monday - Friday 8am-5pm.
Physical Demands
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.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .
#J-18808-Ljbffr