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Supervisor, Visual Inspection Program 503B

Central Admixture Pharmacy

Wescosville, PA

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JOB DETAILS
SKILLS
Auditing, Best Practices, Bug Tracking/Defect Management, Business Practices, Code of Federal Regulations, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cost Control, Current Good Manufacturing Practice (cGMP), Dialysis, Documentation, Drug Manufacturing, FDA (Food and Drug Administration), Healthcare, Internal Audit, Intravenous Therapies, Leadership, Lift/Move 20 Pounds, Medical Products, Nutrition, Ostomy, Pain Management, Performance Management, Performance Metrics, Pharmacy, Philosophy, Problem Solving Skills, Product Programs, Risk Analysis, Root Cause Analysis, Safety/Work Safety, Standard Operating Procedures (SOP), Support Documentation, Systems Administration/Management, Testing, Visual Programming, Wound Care
LOCATION
Wescosville, PA
POSTED
4 days ago
Company: Central Admixture Pharmacy Job Posting Location: Allentown (6580 Snowdrift Rd), Pennsylvania, United States Functional Area: Production Working Model: Onsite Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday Shift: 5X8 Relocation Available: No Requisition ID: 10859 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: Responsibilities: Essential Duties Manage the visual inspection program for sterile products Ensure all inspection activities comply with 21 CFR Parts 210/211, 503B guidance, USP / , and facility SOPs. Maintain validated inspection methods, acceptance criteria and defect classification systems Supervise, train and qualify visual inspectors, ensuring ongoing proficiency through routine vision testing, challenge sets and requalification. Develop training materials and conduct hands-on instruction for defect recognition, inspection technique and cGMP documentation. Schedule inspection personnel to meet production and release timelines. Lead or support investigation related to inspection failures, atypical findings or product defects. Participate in CAPA development, root cause analysis and risk assessments. Evaluate inspection performance metrics (false reject rates, defect trends, inspector performance) Maintain audit-ready inspection process and documentation. Support internal audits, FDA and BOP inspections. Implement correction actions from audit observations related to inspection practices. 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 others Expertise: Knowledge & Skills Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action. Provides direct or indirect 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 all day-to-day problems. Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors. Expertise: Qualifications -Education/Experience/Training/Etc Required: Bachelor’s degree required or equivalent combination of education and experience. Experience in sterile pharmaceutical manufacturing, ideally within a 503B or 21 CFR 210/211 regulated environment. Strong understanding of visual inspection requirements for sterile parenteral products. Prior supervisory or team-lead experience in a cGMP setting 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. 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. PI49ab464d31c2-25448-400972875c143e31-5e48-4549-b638-05792d185386

About the Company

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Central Admixture Pharmacy