Quality Specialist

BioSpace; Templeton (PA); On-site; USD 40,000 - 60,000; Full time

Benefits offered by this job

Health care benefits including medical, dental, and vision

401(k) Savings Program

Paid Time Off (PTO)

Job summary

A leading biotherapeutic company is seeking a Quality Specialist to ensure compliance with operational and quality standards at the plasma collection center. Responsibilities include performing QA reviews, managing training activities, and conducting audits to meet regulatory requirements. The ideal candidate should be detail-oriented with strong customer service and problem-solving skills. This is a full-time entry-level position located in Templeton, Pennsylvania.

Qualifications

• Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment.
• Understand Quality Systems and/or regulated training requirements.

Responsibilities

• Perform final QA review and release for all shipment and associated documents.
• Maintain and review Plasma center personnel training documents to ensure compliance.
• Conduct and lead internal audits to monitor facility compliance and develop responses for deficiencies.
• Promote Safety, Health and Environment Policies & Procedure.

Skills

Strong customer service skills

Strong critical reasoning

Decision-making skills

Problem solving skills

Organizational skills

Attention to details

Education

High school diploma or equivalent

Associate or Bachelor’s degree in business administration or biological sciences

Job description

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The Opportunity

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.

• Reporting compliance status data to operational quality management
• Collaborate with center management in the development and implementation of continuous improvement plans
• Collaborate with Assistant Manager of Quality (AMQ), to represent the center during internal and external audits, respond to questions, and may stop operations, including shipments to address quality concerns
• Responsible for coordinating and managing training activities, policies and processes at the center level

You will report to the Assistant Manager Quality

The Role

• Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.
• 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.
• Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.
• Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.
• Initiate 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
• Collaborate 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.
• 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.
• Identifying and communicate non-conformities to CSL’s SOP’s. In 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.
• Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.
• Conduct 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 deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers.
• 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.
• Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable.
• Follow all Standard Operating Procedures (SOPs), company policies and procedures.
• 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.
• Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.
• Assist Plasma center staff in completing other special projects or assignments, as requested.
• Perform other job-related duties, as assigned.

Your Skills And Experience

Education

High school diploma or equivalent required. Associate or Bachelor’s 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

Working Conditions

• 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

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 CSL’s 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 https://cslbenefits.com/cslp.

About CSLPlasma

CSL Plasma operates one of the world’s largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL 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 company, CSL, headquartered in Melbourne, Australia, employs 32,000 people.

We want CSL to reflect the world around us

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.

Do work that matters at CSL Plasma!

Seniority level

Entry level

Employment type

Full-time

Job function

Quality Assurance

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