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 61,000 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.
· Work in the Quality Assurance Oversight team in the Chemistry labs to perform technical review of associated data and documentation to support batch and material release, to meet business and operations requirement
· Technical Review includes but are not limited to: Documentation of test execution including all lab preparations, instrument setup, and data/result generation, Transfer of data, LIMS, Electronic review of chromatography in Empower software, audit trail, Instrument qualifications/ calibrations, review Chemistry related SOPs, protocols, reports, data (including meta data) and records generated to support the manufacturing and distribution of product.
· Reviews chemistry lab records to ensure data meets the industry requirements for data integrity.
· Ensures that procedures are being followed as outlined under FDA, ICH, Standard Methods, Site Procedures and the Quality System requirements.
· Track review requirements for the released of finished products, Stability and raw materials lots
· Participate on cross-functional teams and provide input and quality oversight to assist with the closure of chemistry related laboratory investigations.
· Perform in support of investigations, CAPAs and effectiveness checks, as related to product testing.
· Perform administrative duties as required in support of chemistry related assessments and investigations.
· Benchmark and apply industry best practices.
· Partners with Corporate Quality to implement centralized processes and ensures compliance to industry standards and compendial requirements.
· Review, compare and update current documentation of processes and equipment functionality/design to comply with FDA’s Code of Federal Regulations 21 CFR Parts 210 and 211.
Expertise: Knowledge & Skills
· Hands on chemistry lab experience preferred with working knowledge of GxP requirements
· Accuracy - Ability to perform work accurately and thoroughly
· Analytical and Problem solving Skills - Ability to use critical thinking and reasoning by weighing all the variables to come up with a resolution to solve a problem. Uses standard theories, principles and concepts and integrates them to propose a course of action.
· Communication, Oral & Written - Ability to communicate effectively with others using the spoken word and in composing clear and concise messages
· Customer Oriented - Ability to take care of the customers’ needs while following company procedures.
· Decision Making – Ability to make decisions for a course of action to be taken to address a specific issue.
· Detail Oriented - Ability to pay attention to the minute details of a project or task.
· Organized - Possessing the trait of being organized or following a systematic method of performing a task.
· Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and checking the work of other peers.
· Bachelor's degree in Biochemistry, Chemistry or related scientific field is strongly preferred.
· Minimum of 3-5 years of experience in the medical device, pharmaceutical or biotechnology industry.
· Familiarity with ICH and FDA guidelines, GMP regulations and quality compliance requirements preferred.
· Must have excellent technical writing skills, editing, formatting and organization skills.
· Proficient in Microsoft Office Suite
· HPLC experience
· Hands on working experience in a chemistry laboratory
· Empower and LIMs experience
Expertise: Qualifications -Education/Experience/Training/Etc
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.
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.
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.
While performing the duties of this job, the employee is expected to:
Lifting, Carrying, Pushing, Pulling and Reaching:
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.
Equal Opportunity Employer Veterans/Disabled