QC Lab Manager II

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:

We are seeking a highly motivated individual to join and lead our Quality Control team at our Allentown facility. The ideal candidate will be passionate about growing and developing our laboratory operations, driving excellence in quality and compliance. A strong background in laboratory methods and standards, as well as hands-on experience with Out-of-Specification (OOS) investigations, is essential. This is an exciting opportunity for a dynamic professional eager to make a significant impact and advance their career within the organization.

Responsibilities: Essential Duties

• Manages the operation of the organization's Quality Control Group, which includes the Quality Control function that conducts physical and analytical product testing, as well as environmental monitoring and control. Ensures department employees comply strictly with established procedures and policies. Oversees the performance of functional groups to ensure that products and processes meet company and regulatory requirements/standards. Ensures continuous compliance of department procedures and practices with changes in regulatory requirements and expectations. Drives continuous improvements for efficiency and effectiveness. Maintains a safe environment for employees in accordance with the site's safety program.
• Responsible for maintaining programs for contamination control, personnel control, and environmental monitoring of controlled environments. Leads continuous improvements to minimize environmental and personnel excursions in controlled environments. Maintains the Drug Stability Program in accordance with regulations and company policies and procedures. Collaborates with the organization to ensure that any new drug products are integrated into the stability program.
• Responsible for maintaining the analytical laboratories in accordance with company policies and procedures to ensure a continuous state of audit/inspection readiness. Takes immediate action to resolve any identified non-compliances and escalates to upper management as required.
• Responsible for the scheduling and execution of product testing in accordance with defined procedures and specifications within required timeframes to meet business objectives and customer needs. Reviews and approves product testing to ensure appropriate material disposition in accordance with company procedures.
• Responsible for the review and approval of nonconformances relating to QC laboratory and manufacturing operations activities, ensuring technical accuracy, completeness, and justifications supporting recommended actions to be taken.
• Responsible for developing and recommending responses to inquiries and audit observations pertaining to quality control accountabilities.
• Responsible for effectively interacting and communicating with Manufacturing, Engineering, Regulatory, Sterilization, and other quality areas to ensure necessary tests are performed and timely resolution of product quality issues is achieved.
• Responsible for staffing, training, coaching, and development of subordinates to maintain and improve product quality and systems consistent with department and company operating objectives. Selects, trains, motivates, and develops a highly technical staff with expertise in good laboratory practices and cGMPs to accomplish department objectives, optimize personnel performance, and achieve personal and professional growth. Coordinates communications to employees, assists in the development of training, monitors results, and administers related reward systems.
• *Responsible for tracking expenditures related to the department budget and financial resources.
• Responsible for performing other related duties as required by management.
• Supervises and coordinates activities of personnel engaged in performing chemical and physical analyses and tests required for research, development or quality control of processes or products.
• Compiles, analyzes and interprets results.
• May investigate complaints on existing products.

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.
• Manages activities of a functional area which has at least 2 departments or major functions through managers and/or experienced employees. Responsible for cost, method, and employee results.
• Judgement is required in resolving complex problems based on experience.
• Consults senior executive management / group board members of BBM on company-wide initiatives and acts as spokesperson on matters regarding policy, capability, and strategy to the organization.

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required, Master's degree preferred.
• 08-10 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance
• Occasional business travel required, 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.

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:Reaching upward and downward, Push/pull
• Frequently:Stand, Sit, Visual Acuity with or without corrective lenses
• Constantly:N/A

Activities:

• Occasionally:Climbing stairs/ladders, Finger feeling, Handling, Hearing - ordinary, fine distinction, loud (hearing protection required), Kneeling/Crawling, Push/pull, Reaching upward and downward
• Frequently:Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Standing, Stooping/squatting, Talking - ordinary, loud/quick, Walking
• Constantly:N/A

Environmental Conditions:

• Occasionally:Proximity to moving parts, Exposure to toxic or caustic chemicals (in most areas)
• Frequently:N/A
• Constantly: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:Moderate
• Occasionally:Production/manufacturing environment
• Frequently:Office environment, Lab environment
• Constantly:N/A

Target Based Range: $108 - $135,413

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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.