QC Chemistry Associate III (Stability Documentation)

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:

The QC Chemistry Associate III is responsible for designing, executing, and coordinating stability program(s) to satisfy annual commercial stability commitments. They will also collaborate with other departments to support stability studies for product development, sustaining and special projects.

Responsibilities: Essential Duties

• Collaborate with QC, R&D, and Regulatory Affairs to identify products, testing criteria and type of stability studies required.
• Author stability protocols prior to the initiation of the stability study.
• Compile analytical data into stability reports and trend the data over the shelf-life of the products.
• Identify and report any out of trend or out of specification data to management.
• Assist with investigations related to stability studies.
• Support Regulatory Affairs by providing stability data for submission of regulatory documents.
• Assist in developing and maintaining site specific, related documents.
• Performs routine laboratory analysis of in Process, finished product, raw material, stability samples and environmental monitoring according to established specifications and procedures using wet chemistry techniques or various laboratory apparatus and instruments (e.g. HPLC, UV/Visible Spectrophotometer, FTIR, TOC, pH meter etc.) in compliance with B. Braun, cGMP, GLPs, SOPs, USP and FDA guidelines.
• Performs routine qualification, calibration and maintenance of laboratory instruments.
• Prepares analytical standards and reagents according to established procedures and specifications.

Expertise: Knowledge & Skills

• Requires working knowledge of technical field/area of specialization. Exercises general application of principles, theories and concepts. Follows established procedures and guidelines.
• Works under general supervision. May periodically assist in orienting, training, assigning and/or reviewing the work of other peers.
• May require some limited judgement in resolving problems.
• Contacts are primarily with direct supervisor, peers and subordinates.

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:

• High school diploma required, Bachelor's degree in a Science related field preferred.
• 02-04 years related experience required.
• Regular and predictable on-site attendance
• 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:Reaching upward and downward, Push/pull, Sit
• Frequently:Stand, Visual Acuity with or without corrective lenses
• Constantly:N/A

Activities:

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

Environmental Conditions:

• Occasionally:Proximity to moving parts, Fumes
• 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
• Frequently:N/A
• Constantly:Lab environment

Equal Opportunity Employer Veterans/Disabled

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