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 .
Responsibilities: Essential Duties
Plans, coordinates and organizes the overall activities of the QC Laboratory according to internal and external standards in a most cost-effective way.
Manages one or more operations / programs within the duties of general Laboratory Administration
Ensures that the necessary tests are done according to the test specification, test method and working instruction and to ensure release on time for pharmaceutical products and medical devices.
Develops instrument and other test methods. Serves as author for qualification protocols and reports.
Responsible for the preparation and updating of the GMP/ISO procedures in the area of responsibility.
Participates in projects, task force jointly with production personnel in case the needs arise.
Performs data compilation, review and performs trend analysis on production processes and possible deviations when required.
Authors and investigates discrepancies and other nonconformances.
Participates in internal and external audit.
Responsible in release of medical devices or Pharma products and Pharma incoming materials.
Supports lab related tasks for process validation.
Provides support for projects by attending and participating in team meetings.
Trains and proactively develops the education standard of the responsible persons.
Bachelor's degree in Microbiology, Biology or related field of scientific field of study, with at least 6 years practical experience.
Experience from pharmaceutical, medical device, cosmetic or other FDA-regulated industries.
Knowledge of microbial taxonomy and significance.
Experience with aseptic gowning, environmental monitoring, sterility testing and bacterial endotoxin testing.
Capacity to review and analyze data, and author reports.
Capacity to perform validation of methods and equipment, authoring protocols and reports.
Excellent written communication skills in order to author SOP's, Work Instructions, policies, forms and other documents
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 full working knowledge of relevant business practices and procedures in professional field.
Uses standard theories, principles and concepts and integrates them to propose a course of action.
Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals.
May periodically assist in orienting, training, and/or reviewing the work of peers.
Judgement is required in resolving all day-to-day problems.
Contacts are primarily with department supervisors, leads, subordinates, and peers.
Occasional contact with external contractors/vendors.
Expertise: Qualifications -Education/Experience/Training/Etc
Bachelor's degree required.
06-08 years related experience required.
Applicable industry/professional certification preferred.
Regular and predictable attendance
Occasional business travel required, Secrecy and invention agreement and non-compete agreement
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.
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:
Moderate work - Exerting up to 40 lbs of force occasionally, and/or up to 20 lbs of force frequently, and/or 10 lbs force constantly to move objects.
Lifting, Carrying, Pushing, Pulling and Reaching:
Occasionally:Reaching upward and downward, Push/pull
Constantly:Visual Acuity with or without corrective lenses
Occasionally:Finger feeling, Handling, Push/pull, Reaching upward and downward, Walking
Frequently:Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Standing, Talking - ordinary, loud/quick
Constantly:Seeing - depth perception, color vision, field of vision/peripheral
Occasionally:Proximity to moving parts
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.
Frequently:Office environment, Lab environment
What We Offer :
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 (url removed).
Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
Equal Opportunity Employer Veterans/Disabled