Supervisor II, Quality Control Microbiology Lab
Company: Allentown Mfg Facility
Posted on: May 16, 2022
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 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 .
Supervises the activities for Microbiology in the Quality Control
Analytical Laboratory and QC Analyst. Ensures testing and
disposition of product in accordance with product specific FDA and
ISO guidelines, quality control procedures and company policies and
procedures. Assists in the maintenance of company policies and
procedures to ensure compliance with regulatory compliance. Operate
in accordance with company policies and procedures, FDA Regulations
and ISO Standards.
Preference is a Medical Technologist working in a Medical or
Hospital Laboratory with hands on Microbiological Skills
demonstrating aseptic techniques and Micro Identification
Strong organizational skills and knowledge of FDA and ISO
Ability to learn new skills related to Environmental Monitoring and
manage supporting documents derived from Facilities for HEPA
Re-Certifications and etc
Ability to adapt and be flexible in work day
Ability to manage and train team
Must have or be able to learn computer databases in support of
operation (examples: deviations and SAP for product release)
High degree of judgement required to solve complex problems
Excellent verbal and written communication skills
Responsibilities: Essential Duties
Supervises employees, tasks and duties related to quality control
Develops, implements and assesses processes and policies designed
to test products and services.
Monitors and evaluates current testing processes, making
recommendations for improvements when necessary.
Enforces regulatory compliance.
Conducts visual and physical inspections of company products and
Monitors the performance of the quality control staff, ensuring
that the quality control department meets organizational
Responsible for personnel actions including (but not limited to)
hiring, performance management and termination.
Review and approve procedures and forms governing the QC Analytical
Laboratory and test data generated in the microbiology
Review, investigate, document, report and assist in the
identification of Out of Specification (OOS) results and product
non-conformances. Assist with corrective actions to preclude the
recurrence of similar issues.
Act as a technical consultant and provide support to the functional
groups within the company on microbial testing requirements and
Provides support during regulatory inspections and customer audits.
Identify and implement quality system improvements when gaps are
identified through audits and departmental reviews
The job function listed is not exhaustive and shall also include
any responsibilities as assigned by the Supervisor from time to
It shall be the duty of every employee while at work to take
reasonable care for safety and health of himself/herself and other
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
Provides direct or supervision to a group of employees, assigning
tasks and checking work at frequent intervals. Accountabilities
include work and people scheduling, performance management and
recommendations for hiring decisions.
Judgement is required in resolving complex problems based on
Contacts are primarily with department supervisors, leads,
subordinates, and peers. Frequent contact with external
Ability to analyze samples to determine Microbial enumeration
methods, absence of specified microorganism and water analysis
including environmental monitoring of production areas.
Devises and develops processes and methods for the solution of
Work under minimal supervision. Relies on experience and judgement
to plan and accomplish assigned goals. May periodically assist in
orienting, training, assigning and checking the work of lower level
employees. Referring only complex problems and issues.
Familiar with Data Integrity and GDP in a Lab environment.
04-06 years related Microbiology, Medical device, Medical
Technology or Pharmaceutical experience required.
Prior Supervisory Experience
Expertise: Qualifications -Education/Experience/Training/Etc
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.
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
Through its "Sharing Expertise -" initiative, B. Braun promotes
best practices for continuous improvement of healthcare products
Keywords: Allentown Mfg Facility, Allentown , Supervisor II, Quality Control Microbiology Lab, Healthcare , Allentown, Pennsylvania
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