Quality Systems Technician

Employer
CSL Behring
Location
Boca Raton, Florida
Posted
Feb 11, 2021
Ref
R-127430
Discipline
Quality, Quality Control
Required Education
High School or equivalent
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

GENERAL SUMMARY
  • Responsible for lifecycle management of company documents and records in support of regulatory requirements and mandates
  • Responsible for review of Quality System Change Management applications to ensure compliance with company policies/procedures and industry regulations/standards
  • Participates/Contributes to Change Management activities to meet the Quality System Department strategic objectives


RESPONSIBILITIES

1 Collaborates with document owners and project leaders to prepare documents for the Document Tracking, Approval and Control (DTAC) system.

2 Uses knowledge of company procedures/policies to assess the change mangement process to ensure documents are formattetd, proofread for clarity and completeness. Monitors electronic approval for documents within DTAC based on established timelines. Notifies document owner/project lead when delays could affect project implementation.

3 Communicates regularly with Learning and Development department regarding DTAC activities to provide appropriate notice of document issuances.

4 Conducts inter and intra departmental training sessions for Change Management activities and the use of DTAC, cGMP, etc. Provides support to document owners/Project Leads for trouble shooting and issues with DTAC.

5 Provides guidance to CSL Plasma US sites for the archival of records to repositories and ensures the security of company, vital, quality and confidential records. Communicates and coordinates with suppliers for transportation and retention services records. Is responsible for retrieval and return of records as requested by internal customers and third parties. Assists with compilation of the listing for records destruction.

6 Conduct/Participate in the audio recordings of documents/forms and the creation of CDs and distribution. Collaborates with and provides feedback to the Learning and Development department regarding scripts for training videos.

7 Maintains department inventory of supplies to support Change Management activities and assists the Quality Systems Management with financial invoices. Interact with external contractors for language translation of documents and document replication activities.

8 Supports Quality Systems Management with the review/archival of quality system documents (donor management systems and equipment validations) from CSL Plasma US sites and external suppliers.

9 Assist the Quality Systems Management in identifying improvement opportunities with departmental systems to ensure robust processes are in place to meet global business needs and industry guidelines. Collaborates with CSL business entities in the US and Europe to assist with departmental projects.

10 Perform other job-related duties as assigned.

JOB SPECIFICATIONS

Education
  • High School Diploma or Associates Degree or an equivalent combination of relevant work experience and education required

Experience
  • Experience working in a highly regulated environment, preferably quality
  • Has a working knowledge of cGMP principles and applications
  • Demonstrated ability to write and communicate technical information
  • Microsoft Office software suite and data base application proficiency
  • Develops/Conducted Adult Education sessions
  • Can demonstrate problem solving skills on a 1 to 1 basis or group setting


Additional Comments
  • American Society of Quality, Certified Quality Improvement Associate desirable

Working Conditions

(physical & mental requirements)
  • Understands complex problems to collaborate and explore alternative solutions
  • Ability to make decisions which have significant impact on the department's creditability, operations and services
  • Ability to compose materials such as detailed reports, work-related manuals, publications to limited scope or impact, etc. and/or to make presentations outside the immediate work unit
  • Approximately 80% of time spent sitting at desk to complete job duties
  • Work in fast paced environment with frequent interruptions
  • Overnight travel required up to 10% of the time


Note: 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.