B. Braun Medical, Inc.QC Laboratory Supervisor II - LAL
US-PA-Allentown Job ID:
Hybrid # of Openings:
Allentown Mfg Facility 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 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 . Responsibilities Position Summary:
Supervises the activities for LAL Quality Control Analytical Laboratory and QC Technicians and Analysts. 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, ISO Standards and Canadian Medical Device Regulations, where applicable.
Responsibilities: Essential Duties
- 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 regulations.
- 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
- Supervises 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 reviews
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
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
Qualifications Expertise: Qualifications -Education/Experience/Training/Etc Required:
- 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
- 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 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:
- Frequently:Reaching upward and downward, Push/pull, Stand, Sit, Visual Acuity with or without corrective lenses
- Occasionally:Push/pull, Reaching upward and downward
- Frequently: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, Walking
- Occasionally:Proximity to moving parts, Exposure to toxic or caustic chemicals (in most areas)
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.
What We Offer
- Noise Intensity:Moderate
- Constantly:Office environment
Equal Opportunity Employer Veterans/Disabled
All 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.