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Description
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, SOP’s, 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 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.
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 deficiencies.
In 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 Health Safety and Environmental (HSE) 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 Assist Plasma center staff in completing other special projects or assignments, as requested.
18 Perform other job-related duties, as assigned.
Education
High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred.
Experience
Working Conditions
physical & mental requirements)
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.
Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company.
Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company.
Last updated : 2024-04-24
Full Time
Transportation
$90k-109k (estimate)
04/26/2024
07/18/2024
cslships.com
MIDDLETON, MA
200 - 500
1845
ROGER M JONES JR
<$5M
Transportation
The job skills required for Quality specialist include Customer Service, Leadership, Problem Solving, Internal Audit, Attention to Detail, Quality Management System, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality specialist positions, which can be used as a reference in future career path planning. As a Quality specialist, it can be promoted into senior positions as a Quality Assurance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality specialist. You can explore the career advancement for a Quality specialist below and select your interested title to get hiring information.
If you are interested in becoming a Quality Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Quality Specialist job description and responsibilities
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Specialists are responsible for establishing and maintaining various documents, reports and following regulation forms.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Quality Specialist jobs
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Most quality specialists will be working as part of a team or managing a team of other quality specialists.
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These quality checks ensure the ongoing reliability of the manufacturing process.
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Step 3: View the best colleges and universities for Quality Specialist.