QC Scientist II-Microbiologist

Overview

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.

 

Responsibilities

Position Summary:

 

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.

Preferred Qualifications:

• 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, 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 advanced knowledge of professional field and industry.
• Influences the development of and drives the application of principles, theories, concepts.
• Determines best 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 complex problems based on experience.
• Contacts are primarily with department supervisors, leads, subordinates, and peers.
• Frequent contact with external contractors/vendors.

 

 

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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Salary range: $65302-$81628

Target Based Range

65302-81628

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

• Bachelor's degree required.
• 08-10 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance
• Occasional business travel required, 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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Additional Information

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:

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

Activities:

• 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

Environmental Conditions:

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

 

Referral Amount

USD $500.00

Notices

Equal Opportunity Employer Veterans/Disabled