QC Process Control Lead I
Location:
Irvine , California
Posted:
October 24, 2017
Reference:
2017-10557
Overview

With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

U.S. Facilities and Operations:

Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

Responsibilities

Position Summary:
Responsible for providing routine work direction and training to other QC Process Control Associates. Responsible for performing in-process inspection and process monitoring, batch record review and release activities, label control and quality investigations/resolution. Process monitoring includes sampling to support the Environmental Monitoring program and manufacturing process verifications to ensure compliance with operating procedures and specifications.
Responsibilities: Essential Duties
  • Provide routine work direction and training to other QC Process Control Associates. Escalate issues to Supervisor as required.
  • Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures. Prepare/revise operating procedures and specifications.
  • Reviews/approves routine change control requests.
  • Perform manufacturing process verifications to ensure compliance with operating procedures and specifications (for example, verify proper line clearance, compliance with operating and inspection procedures, operation of equipment per validated parameters, equipment calibrated, operators trained, compliance with gowning and clean room procedures, etc.).
  • Perform nonviable airborne particle testing, sampling of work surfaces for viable particles, and process water sampling.
  • Perform in-process testing to ensure conformance with process and product release specifications.
  • Responsible for responding to clean room alarms to verify compliance with excursion requirements. Assess status and determine the appropriate actions needed to be taken.
  • Issue and control of product labeling.
  • Review of batch records including control check sheets, notebooks, raw data, reports, certificates of analysis, etc to ensure completeness, accuracy and conformance with specifications.
  • Provide support for quality investigations and resolution of quality issues.
  • Compile, report, and interpret quality trend information.
  • Perform all activities with a working knowledge of company procedures and specifications and government regulations that govern the process.
  • Ensure that all testing is performed according to appropriate procedures and standards.
  • Provide support to the manufacturing operation in areas related to quality from an aseptic standpoint.
  • Review data and assign disposition to test results including but not limited to environmental data, in-process audit results.
  • Maintain sample logs on a daily basis to ensure timely testing and tracking of all samples.
  • Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
  • Maintain current knowledge of regulatory and industry standards, trends and advancements.
  • Conduct routine and non-routine audit and analysis of in-process activities according to established procedures.
  • Demonstrate analytical skills to assess and resolve discrepancies including investigation and preliminary product disposition.
  • Maintain accurate, complete records and ensure documentation is consistent with written procedures.
  • Prepare and revise procedures to comply with cGMP requirements base on current processes and observation results from in-process audits.
  • Provide oversight of specific Standard Operating Procedures for Process control and operations requirements.
  • Work independently and effectively with various quality functions to assure conformance to FDA regulatory requirements, and internal processes and policies.
  • Work effectively across different business units.
  • Self motivated.
  • Uses computerized systems needed for product release and control, document control and quality investigation processes.
  • Prioritize tasks in a high pressure and deadline driven environment.
  • Provide high quality analytical support for quality, manufacturing.
Expertise: Knowledge & Skills
  • Requires good written and verbal communication skills (written report will be required weekly).
  • Requires good analytical and trouble shooting skills.
  • Requires good organization and computer skills.
  • Requires good leadership and training skills.
  • Requires advanced and specialized expertise, typically developed through a combination of job-related training and considerable on-the-job experience.
  • Ability to complete assignments and facilitate the work activities of others; may coordinate work beyond own area.
  • Ability to analyze and propose process improvements.
  • Ability to work autonomously within established procedures and practices.


Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc
Required:
  • Bachelor's degree in a related field with 4 years of related work experience or an equivalent combination of education and experience.
Desired:
  • Bachelor's degree in Biology including a Microbiology course or a scientific discipline is strongly preferred.
  • Work experience in a GMP laboratory or manufacturing environment is preferred.
  • Experience working in aseptic pharmaceutical manufacturing process is preferred.
  • Familiar with FDA regulations pertaining to pharmaceutical manufacturing is preferred.
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 30 pounds.

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 Equal Opportunity Employer Minorities /Women/ Veterans/Disabled.
Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Other

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 employee must occasionally lift and/or move up to 30 pounds.
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.

A little about us:
One of the world's leading healthcare suppliers.

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