B. Braun

QA Process Control Lead - CAPS

Job Locations US-AZ-Phoenix
Requisition ID
2020-16817
Company
Central Admixture Pharmacy Services, Inc.
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
Monday through Friday, 7am - 3:30pm
Site
CAPS

Overview

CAPS®, the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation’s largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
CAPS is part of the B. Braun Group of Companies in the U.S.

Responsibilities

Position Summary:

This position requires a hands-on high-level expertise in quality assurance for compounding processes. The QA Process Control Lead will be responsible for supervising routine work, providing direction, and training to Quality Control Coordinators (QCC). Responsible for performing in-process inspection and process monitoring, batch record review and release activities, label control and quality investigations/resolution, process verifications to ensure compliance with operating procedures and specifications.

Responsibilities: Essential Duties

  • Recommend and/or implement improvements in streamlining processes and procedures in the areas of compounding, validation, change control, laboratory, and risk assessments.
  • Lead root cause analysis and corrective and preventive actions for audit observations, product complaints, product non-conformances, in-process deviations, CAPA, and SCAN issues related to process controls.
  • Direct the investigation of excursions in Manufacturing or other related operations. Resolves nature of the cause, impact on product quality, disposition and corrective actions.
  • Supervise routine work, provide direction, and training to QCCs.
  • Ensures the efficient use of resources in order to achieve department quality and operation plan objectives.
  • Performs final review of test data/reports to ensure conformance to the established specifications and standard operating procedures.
  • Writes collects, organizes and compiles data and reports to provide information for use by management or to comply with goals and regulatory requirements.
  • Prepare/revise operating procedures and specifications.
  • Review/approve routine change control requests as designated.
  • Perform compounding 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.)
  • Responsible for responding to clean room alarms to verify compliance with excursion requirements. Assess status and determine the appropriate actions needed to be taken.
  • Control of product labeling/Label accountability.
  • 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.
  • Review data and assign disposition to test results including but not limited to environmental data, in-process audit results.
  • Maintain current knowledge of regulatory and industry standards, trends and advancement.
  • Conduct routine and non-routine audit and analysis of in-process activities according to established procedures.
  • Maintain accurate, complete records and ensure documentation is consistent with written procedures.
  • Prepare and revise procedures to comply with cGMP requirements based on current processes and observation results from in process audits.
  • 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.
  • 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.
  • Oversee process controls to ensure product quality and all specifications are met. Ensure products are released on time and within specification.

Expertise: Knowledge & Skills

  • Good working knowledge of Pharmaceutical (USP <797>, 21 CFR 210 & 211, and 503B)
  • Good working knowledge of USP, FDA/cGMP, ISO, and ICH requirements
  • Effective communication skills, both written and verbal.
  • Leadership skills and the ability to facilitate the work activities of others
  • Ability to act effectively as a member of a team to resolve problems.
  • Ability to analyze and troubleshoot
  • Advanced and specialized expertise, typically developed through a combination of job-related training and considerable on-the-job experience.
  • Good organizational and time management skills
  • Good computer skills
  • Ability to complete assignments timely

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

  • BS degree in technical or scientific discipline and five or more years of related experience preferably in the pharmaceutical and or medical device industry.
  • Ability to work autonomously within established procedures and practices.
  • Experience with USP, cGMP’s, and FDA guidelines.
  • Valid driver license required
  • May be required to travel approximately 20% per calendar year

Desired:

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.

 

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 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.

Notices

Equal Opportunity Employer Veterans/Disabled

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