Supervisor II, Quality Control Microbiology Lab
Company: B. Braun Medical
Location: Allentown
Posted on: May 16, 2022
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Job Description:
B. Braun Medical, Inc.Supervisor II, Quality Control
Microbiology LabUS-PA-AllentownJob ID: 2022-20211Type: Regular
Full-Time# of Openings: 1Category: QualityAllentown Mfg
FacilityOverviewAbout 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.ResponsibilitiesPosition Summary: 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 IdentificationStrong
organizational skills and knowledge of FDA and ISO
regulations.Ability to learn new skills related to Environmental
Monitoring and manage supporting documents derived from Facilities
for HEPA Re-Certifications and etcAbility to adapt and be flexible
in work dayAbility to manage and train teamMust 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 problemsExcellent verbal and written
communication skillsResponsibilities: Essential DutiesSupervises
employees, tasks and duties related to quality control within
organization. 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
materials. Monitors the performance of the quality control staff,
ensuring that the quality control department meets organizational
objectives.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
laboratory.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 techniques. Provides support
during regulatory inspections and customer audits. Identify and
implement quality system improvements when gaps are identified
through audits and departmental reviewsThe 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.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 experience.Contacts are primarily with department supervisors,
leads, subordinates, and peers. Frequent contact with external
contractors/vendors.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 technical problems.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 QualificationsExpertise: Qualifications
-Education/Experience/Training/Etc Required:Bachelor's degree
required.04-06 years related experience required.Applicable
industry/professional certification preferred.Regular and
predictable attendanceSecrecy 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
www.bbraunusa.com. Through its "Sharing Expertise--" initiative, B.
Braun promotes best practices for continuous improvement of
healthcare products and services. 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: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:N/AFrequently:Reaching upward and downward,
Push/pull, Stand, Sit, Visual Acuity with or without corrective
lensesConstantly:N/AActivities:Occasionally:Push/pull, Reaching
upward and downwardFrequently:Finger feeling, Handling, Hearing -
ordinary, fine distinction, loud (hearing protection required),
Seeing - depth perception, color vision, field of
vision/peripheral, Sitting , Standing, Talking - ordinary,
loud/quick, WalkingConstantly:N/AEnvironmental
Conditions:Occasionally:Proximity to moving parts, Exposure to
toxic or caustic chemicals (in most areas)
Frequently:N/AConstantly: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:ModerateOccasionally:N/AFrequently:N/AConstantly:Office
environment What We Offer..NoticesEqual Opportunity Employer
Veterans/DisabledAll qualified applicants will receive
consideration for employment without regard to race, color, sex,
sexual orientation, gender identity, religion, national origin,
disability, veteran status, age, marital status, pregnancy, genetic
information, or other legally protected status.PI177343840
Keywords: B. Braun Medical, Allentown , Supervisor II, Quality Control Microbiology Lab, Healthcare , Allentown, Pennsylvania
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