Sr Quality Specialist

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.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com

Job Title:Sr Quality Specialist

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.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visitwww.bbraunusa.com

Position Summary:

The Senior Quality Specialist will have in depth working knowledge of analytical chemistry, microbiology, and physical test methods, including USP requirements, ICH guidelines, EP requirements, ISO standard requirements, AAMI requirements, and ASTM requirements. The Sr. Quality Specialist works collaboratively with Research & Development, internal and external manufacturing site Quality Control laboratories for new products and maintenance for commercial products, and provides quality support for analytical method development, validation, verification to ensure compliance to regulatory requirements. The Sr. Quality Specialist is responsible for data integrity program for Corporate Pharma R&D.

Responsibilities: Essential Duties

• Support authoring analytical method verification protocols and associated reports, as well as approve method validation or method transfer protocols and reports to meet regulatory requirements (USP / NF, ICH, and other relevant guidelines).
• Support analysis of data related to testing, support out of specification investigations, CAPA investigations, and trouble shoot Quality Control issues as SME.
• Stay informed of all relevant regulatory requirements and collaborates with R&D, site Quality Control and Quality Systems excellence to ensure compliance.
• Conduct the Quality Assurance Oversight (QAO) review and analyze data from research and development quality processes to ensure data integrity.
• Provides quality oversight for laboratory compliance including but not limited to equipment, instrument, chemicals, procedures, documentation, and quality investigations.
• Coordinate responses to regulatory draft documents for BBMI centrally, such as the Pharmacopeia forum, PDA draft documents, and USP draft updates including potential new monographs (if applicable).
• Execute the strategic direction for Quality by Design concepts and beginning-to-end product lifecycle management to improve efficiency, maintain compliance with regulatory requirements, and minimize risk to product quality and successful product introduction and lifecycle management.
• Partner with cross functional and cross site teams to maintain compliance with compendial requirements, including specifications, methods, change controls, SAP/LIMS master data, and site communication.
• Apply lean and six sigma principles to ensure quality system processes are compliant, efficient, and effective. Participate in or lead continuous improvement projects with diverse team members to achieve desired results.

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 of himself/herself and other persons.

Expertise: Knowledge & Skills

• Expertise in USP analytical methods and general chapter compliance
• Expertise in ICH guidelines, namely related to analytical method development, validation, impurities, stability, and risk management
• Expertise in FDA requirements for pharmaceuticals and medical devises
• Influences the development of and drives the application of principles, theories, concepts.
• Determines best course of action with sound judgment.
• Work under minimal supervision.

#LI

#MSL

$101,167 - $126,459

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required in Scientific discipline.
• 10+ years related experience in analytical chemistry or microbiology to support medical device/pharmaceutical industry.
• 2+ years of experience with central quality management role and LIMS/SAP experience
• Occasional business travel required

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:Sit, Visual Acuity with or without corrective lenses
• Constantly:N/A

Activities:

• Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking
• Frequently:Finger feeling, Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick
• Constantly:N/A

Environmental Conditions:

• Occasionally:Proximity to moving parts
• 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:Moderate
• Occasionally:Production/manufacturing environment, Lab environment
• Frequently:N/A
• Constantly:Office environment

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its "Sharing Expertise" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

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.