Assistant Manager of Quality

Employer
CSL Behring
Location
Philadelphia, Pennsylvania
Posted
May 16, 2022
Ref
R-165297
Discipline
Quality, Quality Control
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Job Description

Job Description

  • You will ensure center is "inspection ready" by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, using sound Quality principles, self-inspection insights, non-conformity discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center.
  • You will manage site Quality Control program including calibrations monitoring of compliance to defined processes e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of Measurements, cause and failure mode impact assessment and change management.
  • You will lead direct reports ensuring they are competently accomplished to perform their QA roles. Upon proper review with center and quality management, hire, conduct performance reviews and enact corrective actions, up to and including termination.
  • Participate with management to develop programs and methods to refine center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality.
  • Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies.
  • Lead and function as the main quality representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of audits. Use quality tools and applications to facilitate understanding of issues and documentation.
  • Maintain clean efficient work environment and ensure operating supplies and availability of forms. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) procedures. Conduct routine audits of internal procedures and documentation.
  • Follow all HR practices through fair treatment of all employees and comply with all federal, state and local regulatory and company procedures.

Education

  • Bachelor's Degree OR equivalent combination of education and professional work experience required

Experience

  • Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others, OR
  • 1year Quality experience (CSA/CSAb) required OR
  • Completion of CSL Plasma Leadership Development program

Additional Comments

  • Maintain company Technical Training certification
  • Knowledge of complex government and industry regulations, and ability to monitor compliance with these regulations
  • Manage entire financial responsibility of the center
  • Proficient in English
  • Bachelor's degree in scientific discipline/life sciences or related discipline
  • 5+ years' experience related to quality and regulatory/ Plasma industry experience
  • Demonstrated leadership experience
  • Knowledge of government and industry regulations

Working Conditions

(physical & mental requirements)

  • Ability to make decisions which impact on the department's creditability, operations and services
  • Ability to formulate complex and comprehensive materials such as reports of major scope and effect and to make formal presentations
  • Frequently exposed to hazardous chemicals, extreme temperatures and to bloodborne pathogens
  • Overnight travel required up to 10% of the time
  • Generally spend 80% of the time standing and walking and 20% of time sitting
  • Occasionally lift and carry up to 25 lbs.
  • Exposure to hot and cold temperatures, sudden temperature changes working with freezers and different odors
  • Exposure to human source products and multiple chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, and germicide solution.
  • Required to wear Personal Protective Equipment while performing specific tasks or in certain areas

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.

#CB

#CB

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Plasma

CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

Do work that matters at CSL Plasma!