Supervisor II, QC Chemistry/Stability

About B. Braun

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.

Position Summary:

• Direct supervision of six (6) laboratory employees performing Stability and Chemistry testing for raw material and finished product release.
• Performs, monitors, review, and approves validation of test methods, and laboratory instruments.
• Creates, reviews, and approves stability protocols.
• Reviews and approves OOS investigations and approves retest plans.
• Complete nonconformance investigations and reviews and approves nonconformances.
• Performs impact assessments, and completes change control assessments.
• Hands-on experience in the operation, interpretation and troubleshooting of a GC, HPLC, FT-IR, UV-VIS and other chemistry laboratory instrumentation.
• Develop, validate (TMV) and qualify test methods against applicable standards to support GLP and QSR requirements.
• Train employees to perform simple and complex analytical tasks and testing.
• Coach, mentor, and develop Direct Reports to have a good internal succession plan.
• Follow all applicable Data Integrity guidelines and adhere to current GDP policies.
• Enforces regulatory compliance.

Responsibilities: Essential Duties

• Supervises employees, tasks and duties related to quality control within organization.
• Develops, implements and assesses processes and policies designed to test products and services.
• Monitors and evaluates current testing processes, making recommendations for improvements when necessary.
• Enforces regulatory compliance.
• Conducts visual and physical inspections of company products and materials.
• Monitors the performance of the quality control staff, ensuring that the quality control department meets organizational objectives.
• Responsible for personnel actions including (but not limited to) hiring, performance management and termination.
  

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

• 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.
• Provides direct or supervision to a group of employees, assigning tasks and checking work at frequent intervals. Accountabilities include work and people scheduling, performance management and recommendations for hiring decisions.
• 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.

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.

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Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required.
• 04-06 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance
• Secrecy and invention agreement and non-compete agreement, Ability to work non-standard schedule as needed

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.

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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:N/A
• Frequently:Reaching upward and downward, Push/pull, Stand, Sit, Visual Acuity with or without corrective lenses
• Constantly:N/A

Activities:

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

Environmental Conditions:

• Occasionally:Proximity to moving parts, Exposure to toxic or caustic chemicals (in most areas)
• 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:N/A
• Frequently:N/A
• Constantly:Office environment

Equal Opportunity Employer Veterans/Disabled

PI256171958