Quality Specialist
Quality Specialist
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Job Description
Responsibilities:
1 Perform final QA review and release for all shipment and associated documents to ensure shipment meets customer specifications.
2 Ensure center records QA review to ensure thoroughness accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action ensure appropriate documentation and determine effectiveness of the action.
3 Perform center records QA review to ensure thoroughness accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action ensure appropriate documentation and determine effectiveness of the action.
4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures SOPs CLIA/COLA and other applicable requirements.
5 Maintain the Learning Management System to ensure data integrity report generation and data analysis to comply with company and regulatory standards.
6 Initiates schedule coordinate and monitor the delivery of all training such as new hire annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used
7 Collaborates with center management when viewing the Quality Management System to identify coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues.
8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans as necessary in partnership with management.
9 Identifying and communicate non-conformities to CSLs the absence of the AQM may conduct monthly quality team meeting to inform promote assess and identify opportunities for continuous process improvement in quality safety and training for implementation.
10 Promote Safety Health and Environment Policies & Procedure. Ensure safety training and safety practices are
implemented and followed within the center.
11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies cGMP OHSA FDA and other regulations as applicable and develop center responses for the absence of the AQM host external audits conducted by the regulatory agencies and customers.
12 Responsible to initiate investigate and close TrackWise reports in a timely manner. Confirm through follow-up to ensure appropriate corrective action was initiated implemented and effective.
13 Maintain clean efficient work environment. Comply with all Environmental Health & Safety (EHS) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits as applicable.
14 Follow all Standard Operating Procedures (SOPs) company policies and procedures.
15 Comply with all local state and federal regulations and laws to include but not limited to: ADA Civil Rights EEOC FDA GHA HIPAA and OSHA.
16 Maintain confidentiality of all personnel donor and center information. Understand policies and procedures associated with hyperimmune programs at the center if applicable.
17 Bilingual skills may be required at the discretion of the organization to meet the needs of the business.
18 Assist Plasma center staff in completing other special projects or assignments as requested.
19 Perform other job-related duties as assigned.
JOB SPECIFICATIONS
Education
- High School diploma or equivalency required
- Associate or Bachelors degree in business administration or biological sciences preferred
Experience
- Minimum 1-year leadership experience or equivalent of one-year experience in a regulated
environment
- Strong customer service skills
- Strong critical reasoning decision-making and problem solving skills to analyze situations
- Organizational skills and attention to details to handle multiple tasks short deadlines frequent interruptions and shifting priorities in support of changing company objectives
- Understand Quality Systems and/or regulated training requirements
Additional Comments
- Minimum travel required
- Bilingual skills preferred at the discretion of the organization to meet the needs of the business. This could be Spanish French Russian or other non-English languages
- Work in a fast paced dynamic environment
- Learn new processes and quickly engage in assignments to drive for action
- Attention to detail and ability to follow written and verbal directions in exact detail required
- Frequently required to make and accept modifications to working processes and procedure per SOP
- Make decisions in accordance with established policies and procedures
- Exercise independent and good judgment to refer decisions when decisions fall out to the realm of established guidelines
- Lead teams without the benefit of a direct reporting relationship
- Maintain technical competencies in all areas
Working Conditions (physical & mental requirements)
- Occasionally required to work with the public when they are dissatisfied
- 80% of the time standing and walking and 20% of the time sitting
- Reach bend kneel and have high level of manual dexterity
- See and speak with customers and observe equipment operation
- Occasionally be required to lift and carry 25 lbs.
- Exposure to hot and cold temperatures sudden temperature changes working with freezers and various odors
- Exposure to human source products and various chemicals including isopropyl ethyl alcohol carbon dioxide iodine bleach germicide solution etc.
- Required to wear Personal Protective Equipment while performing specific tasks or in certain areas
- Work in fast paced environment with frequent interruptions
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.
Our Benefits
CSL offers the following benefits for this full-time position: Options for health care benefits including choices of plans for medical dental and vision prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSLs 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations illness and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit CSLPlasma CSL Plasma operates one of the worlds largest and most sophisticated plasma collection networkswith over 350 plasma collection centers in the U.S. Europe and China. Headquartered in Boca Raton Florida CSL Plasma is a subsidiary ofCSL Behring a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent companyCSLheadquartered in Melbourne Australia employs 32000 people. At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL.We want CSL to reflect the world around us
Do work that matters at CSL Plasma!
Required Experience:
Unclear Seniority
Employment Type
Full-Time
