QC Laboratory Associate II

Company: B Braun US Device Manufacturing LLC
Location: Allentown
Posted on: May 4, 2025

Job Description:

B. Braun Medical, Inc.


Company: B. Braun US Device Manufacturing LLC
Job Posting Location: Allentown, Pennsylvania, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 4656

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
Position Summary: The QC Laboratory Associate II is responsible for fulfilling the needs of the Quality Control Department's requirements for analytical testing in the biological and chemical areas, examination of product, components and performing equipment and process validations. The QC Laboratory Associate II is responsible for performing independent tasks of moderate complexity with some guidance from the higher-level positions, demonstrate some problem solving skills. The position is also responsible for the laboratory daily organizational duties. Responsibilities: Essential Duties

• Perform laboratory testing related to product release in accordance with FDA and ISO guidelines,
• Follow internal policies, standards, and procedures relating to their job specific duties,
• Training to current practices and be skills assessed on those practices,
• Interface with cross functional teams and ensure positive working relations in a professional manner,
• Perform activities required for the execution of the laboratory test methods;
• Maintain laboratory equipment cleaning and servicing;
• Tracking and communication on laboratory inventory of supplies;
• Perform GxP and general laboratory functions as required;
• Performs data entry in various formats, as required, to support departmental needs.
• Support departmental goals and objectives by contributing on continuous improvement initiatives.
• Adhere to all safety and laboratory rules.
• Operate in accordance with company policies and procedures, FDA Regulations, ISO Standards, USP, NF, and Canadian Medical Device Regulations where applicable.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
  • Chemistry knowledge and skills as it pertains to a GxP laboratory;
  • LAL knowledge and skills as it pertains to a GxP Laboratory;
  • Stability knowledge and skills as it pertains to a GxP Laboratory;
  • Microbiology knowledge and skills as it pertains to a GxP Laboratory.
  • Moderate understanding of Lab theories and practices;
  • Moderate understanding of Data Compilation Techniques;
  • Efficient use of laboratory Electronic Measuring Devices and Scientific Instrumentation;
  • Moderate understanding of scientific writing, and oral presentation;
  • Moderate understanding of mechanical aptitude towards equipment;
  • Moderate understanding of operational excellent principles;
  • Able to be organized, meet timelines, and communicate effectively;
  • Able to show initiative and work independently as well as with a team;
  • Able to interpret scientific data and draw conclusions based on the data;
  • Daily use of computer programs including Word, Excel, Outlook;
  • Must be well organized / detail-oriented to meet deadlines.
  • Have the ability to prepare, process, and file documents.
  • Must have people skills, writing, and oral presentation skills.
    Supervision Given and Received:
    • Works under general supervision.
    • May periodically assist in orienting, training, assigning and checking the work of peers.Expertise: Qualifications -Education/Experience/Training/Etc Required:
      • BS degree from a four year college in a science discipline, with a minimum of 3 years related experience or equivalent combination of education and experience as a Laboratory Associate.
      • Must have some experience in QA/QC, FDA, ISO, OSHA, GLP, cGxP, and QSR,
      • 5 years experience in the biological or chemical sciences.
      • Completed required Internal Training and passed required assessments.
      • QA / QC / QE / QSR / GMP / ISO / FDA Training. 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:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Strength:
        • Light work - Exerting up to 25 lbs. of force occasionally, and/or up to a negligible amount of force frequently, and/or a negligible amount of force constantly to move objects.Lifting, Carrying, Pushing, Pulling and Reaching:
          • Occasionally lift or carry up to: 25 lbs.
          • Frequent lift or carry up to: N/A
          • Occasionally: N/A
          • Frequently: Reaching with hands and arms
          • Constantly: N/AActivities:
            • Occasionally: Sitting, stooping, kneeling, crouching, talking, and hearing
            • Frequently: N/A
            • Constantly: Standing, walkingEnvironmental Conditions:
              • Noise Intensity: Moderate
              • Occasionally: N/A
              • Frequently: N/A
              • Constantly: N/AWork 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: N/A Target Based Range: $54,042 - $64,853 #LI
                  #AL
                  
                  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.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.We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.
                  
                  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.
                  
                  Compensation details: 54042-64853 Yearly Salary
                  
                  
                  
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Keywords: B Braun US Device Manufacturing LLC, Levittown , QC Laboratory Associate II, Healthcare , Allentown, Pennsylvania