Quality Specialist
BioSpace
Elyria, OH
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 be able to represent the center during internal and external audits, responds 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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 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.dd 4-6 key responsibilities of the job
- 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
- 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
Posted 2025-08-07
Recommended Jobs
Customer Service Representative
Globe Metallurgical
Marietta, OH
Job Description Job Description Who we are Ferroglobe is one of the world’s leading suppliers of silicon metal, silicon-based and manganese-based specialty alloys and ferroalloys, serving a …
View Details
Posted 2025-07-27
Patrol Officer Step 1
National Testing Network
North Ridgeville, OH
NORTH RIDGEVILLE, CITY OF 7307 AVON BELDEN RD NORTH RIDGEVILLE, OHIO 44039 440-353-0513 Updated: January 13, 2025 ***Please submit your application through the link provided (where more infor…
View Details
Posted 2025-07-27
Apartment Community - Housekeeper
Monarch Investment
Toledo, OH
Description Why just settle for another job when you can be growing your career with a group that doesn't have opportunity knocking, but has it pounding down your door and giving you a real key t…
View Details
Posted 2025-08-06
Police Officer
National Testing Network
Dublin, OH
DUBLIN, CITY OF 6565 COMMERCE PARKWAY DUBLIN, OHIO 43017 Updated: January 06, 2025 ***Please submit your application through the link provided (where more information and links are included), …
View Details
Posted 2025-07-28
Police Dispatcher/Records Clerk
National Testing Network
Streetsboro, OH
STREETSBORO CITY OF 9184 STATE ROUTE 43 STREETSBORO, OHIO 44241 3306264942 Updated: January 24, 2025 ***Please submit your application through the link provided to be considered for this posit…
View Details
Posted 2025-07-27
Prep Cook, Nationwide Arena
Nationwide Arena - Delaware North
Columbus, OH
The opportunity Delaware North Sportservice is searching for part-time Prep Cooks to join our team at Nationwide Arena in Columbus, Ohio. As a Prep Cook, no day will be the same working in …
View Details
Posted 2025-08-06
Housekeeper
Otterbein SeniorLife
Pemberville, OH
Job Description Job Description Overview Otterbein has an employment opportunity for a Full-Time Housekeeper . The Housekeepers provide a clean, safe environment for residents, guests and empl…
View Details
Posted 2025-07-28
Certified Canine Rehabilitation Practictioner
Ethos Veterinary Health
Cincinnati, OH
Care Center located in Cincinnati, OH is searching for a Certified Canine Rehabilitation Practitioner (CCRP)!Are you passionate about helping animals regain strength, mobility, and quality of life t…
View Details
Posted 2025-07-28
3rd Shift Maintenance Tech FULL TIME
Herr Foods Inc.
Chillicothe, OH
Job Description Job Description Description Building a great career never tasted so good! Herr Foods Inc. is a privately owned salty snack food manufacturer and distributor based in Nottin…
View Details
Posted 2025-07-30
Sous Chef
The Capital Grille
Cincinnati, OH
For this position, pay will be variable by location - See additional job details and benefits below The Sous Chef is responsible for supporting the Executive Chef in leading a team of culin…
View Details
Posted 2025-07-30