QC Microbiologist I

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.

Position Summary:

Responsibilities: Essential Duties

* Plans, coordinates and organizes the overall activities of the Microbiological Laboratory according to internal and external standards in a most cost effective way.
* Direct responsible for the supervision test operation at all time for Sterility Testing, Bacterial Endotoxin Test, Microbiological Identification Sections and handling of laboratory OOS result.
* Ensures that the necessary microbiological 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.
* 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.
* Prepares trend analysis and data compilation on deviation in the production process when required.
* Participates in internal and external audit.
* Participates in the Global Microbiology Task Team, whenever required.
* Responsible in microbiological release of medical devices or Pharma products and Pharma incoming materials.
* Supports microbiological tasks for process validation.
* Trains and proactively develops the education standard of the responsible persons.

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. Frequent contact with external contractors/vendors.

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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.

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, Stand, Visual Acuity with or without corrective lenses
• Frequently:Sit
• Constantly:N/A

Activities:

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

Equal Opportunity Employer Veterans/Disabled

PI254893220