QA Manager- Product Release

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:

Manages the activities of product release associates in support of the Irvine facility. Maintains accurate daily status for all manufactured lots including SAP quantities in quarantine. Operates in accordance with company policies and procedures and FDA Regulations.

Responsibilities: Essential Duties

• Assure that controls are in place to effectively and accurately release lots that have met all release criteria, while ensuring all discrepant lots are held until appropriate disposition.
• Directly supervise the work activities of employees engaged in product release processing to assure that products and processes meet company and regulatory requirements/standards.
• Ensure compliance to all regulatory requirements for creation, revision, processing, filing, on-site and off-site storage, retrieval, and disposition of finished product batch records.
• Assure continuous improvement of methods to eliminate wasteful practices within all aspects and contributors to the lot release process.
• Coordinate with Scheduling and Validation departments to ensure all affected lots are held until successful PQ/PV and/or CBE-30 are finalized prior to lot release.
• Identify timely resolution for errors in batch records and on product Certificates of Analysis. Implement appropriate corrective actions to reduce delays in the product release process and ensure customer satisfaction.
• Confirm timely Certificate of Analysis generation for Customers
• In collaboration with the MRBs, identify, prioritize and drive toward investigation conclusion to support lot disposition as an effective MRB team member.
• Appropriately escalate significant quality issues hindering lot disposition as a liaison to the Quality Director. This includes any and all compliance gaps that are observed.
• Track, monitor, publish KPIs.
• Provides SME support during regulatory inspections and customer audits regarding product release processes and impacted batch files.
• Provides support in Corrective and Preventive Actions (CAPAs) and improvement projects regarding product lease processes.
• Provides support to Quality Engineering (QE) and Quality Control (QC) regarding impacted batch disposition.
• Ensure personnel are trained in accordance with department curriculum. Additionally, responsible for the development, motivating and counseling of subordinate staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Effectively communicate a variety of personnel actions; e.g., employment, termination, performance and salary reviews, disciplinary actions, scheduling and/or approving overtime.
• Provide input to budget development and ensure operations within approved department budget. Actively contribute to cost control methods.
• Performs other related duties as required by management which can include special projects or organizational initiatives.

Expertise: Knowledge & Skills

• Knowledge of quality policies, FDA Regulations for pharmaceutical operations.
• Mastery of Product Release processing and associated requirements.
• Strict attention to detail required. Problem detection ability a must.
• Ability to effectively work with all functional groups and levels within the organization.
• Excellent written and verbal communication and interpersonal skills
• Proficient in the use of computer software including a wide variety of SAP modules, EXCEL spreadsheet and Microsoft Word processing.
• Sufficient human relations skills to effectively staff and manage relevant personnel and functions to assure that company goals are met.

Preferred Requirements:

• Pharmaceutical and/or Medical Device experience preferred.
• 8-10 years of related experience with Product Release and Quality.

Salary Range: $111,288 - $139,105

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• BA/BS degree in related science and 8 or more years of experience in a pharmaceutical or medical device company.
• 2-3 years previous supervisor/managerial experience.

Desired:

• Knowledge of B. Braun manufacturing processes and documentation
• Working knowledge of SAP
• Working knowledge of BDocs

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.

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 functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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. The noise level in the work environment is usually moderate.

Equal Opportunity Employer Veterans/Disabled

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.

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