Quality Associate II
: Job Details :

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.

n this vital role you will support the B. Braun's Injectable Drug Product Quality Assurance team under the Plant QA organization providing daily oversight of the LVP Irrigation and WMS manufacturing areas. Under general supervision by team lead, the role provides support and compliance oversight to Manufacturing, Reinspection and Engineering staff in the execution of their processes, procedures, and use of quality tools. The team provides floor support primarily for resolution of finished product manufacture and process quality related issues.

This position is also to support Reserve Samples program, samples staging, replacements and visual inspections, as well as monitoring of rework/reinspection activities, including visual and AQL inspections. After the training period this role will support Quality Mentorship program, Process Verifications program, Annual Reserve Samples Inspections program.

Responsibilities: Essential Duties

• Monitors manufacturing process verifications to ensure compliance with operating procedures and specifications. -Provides support for quality investigation which includes initiation and supporting data for the resolution of quality issues.
• Provides Quality oversight over the Quality System, including but not limited to the review, reports, data (including Meta data) and records generated to support the manufacturing and distribution of product.
• Conducts timely Quality review of associated data, including data utilized to support batch release, to meet business and operations requirements.
• Assists in complying with regulatory requirements related to product safety and quality.
• Ensures that procedures are being followed as outlined under FDA, ICH, Standard methods and the Quality System requirements.
• Reviews records to ensure data meets the industry requirements for data integrity.

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

• Please refer to the Corporate Guidelines or BBMUS Guidelines or job specific authorities where applicable. This list is however not exhaustive and may be amended by the Management from time to time.
• Assignments are routine and repetitious in nature. Work performed within narrowly defined parameters. Follows established procedures and guidelines.
• Works under direct supervision and from detailed verbal and/or written instructions. Uses established procedures to accomplish assigned task.
• May require some limited judgement in resolving problems.
• Contacts are primarily with direct supervisor, peers and subordinates.
• Ability to work non-standard schedule as needed

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.