Quality Regional/quality Document Control - Irvine, United States - ABO Plasma

ABO Plasma

Verified Company

Irvine, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

Classification:
Salaried/Exempt

Reports to:
Director of Quality Assurance & Regulatory Affairs

PURPOSE

Assist the Director of QA/RA in achieving center quality goals while ensuring centers adhere to Standard Operating Procedures, Current Good Manufacturing Principles, and Company Policies.

General Requirements—Adhere to all Standard Operating Procedures, Current Good Manufacturing Practices, Company Policies, Consignee Requirements, and Applicable Regulations.

ESSENTIAL RESPONSIBILITIES & DUTIES

Responsible for reviewing and approving critical error reports (Deviations, issues, lookbacks, post donation information reports, and BPDRs). Consistently track each error report to completion. Responsible for final submission of all BPDRs and lookbacks.
Perform document control functions to assist with writing, revising, and implementation of policies and procedures.
Perform internal center audits of ABO Plasma centers. These audits will be onsite with support of offsite record reviews and requests.
Supervising the center Quality Managers and the production process to make sure that all products meet consistent standards.

HAS AUTHORITY TO:
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_ Instruct any and all facilities to stop production__ _**:

if the strength, purity, identity, or quality of the unit is in question or if donor safety has been compromised.

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_ Instruct any and all facilities to stop the release of shipments_ - if the release of a shipment does not meet any of the required standards as set forth in the SOP.

ASSIST THE DIRECTOR OF QA/RA TO PERFORM THE FOLLOWING:

Assist in development and utilization of Quality management team (Center Quality Manager, Trainer, QA Coordinator).
Review deviations, issues, and assist facilities to resolve compliance issues.
Review post donation information reports to ensure proper actions taken by center.
Review BPDRs for accuracy and ensure their timely submission.
Review Lookback Reports for accuracy and ensure their timely submission.
Must have working knowledge and follow Consignee's specifications regarding the collection of plasma and shipment of units.
Must have knowledge of and ensure compliance the required Federal, State and local regulations as they pertain to each facility.
Must maintain an understanding of all functions of center activities.

Document Control

Responsible in maintaining company policies, procedures, and documents.
Travel to ABO Plasma centers for the purpose of Auditing, Training, or departmental support.

OTHER RESPONSIBILITIES

Accept other assignments as delegated by Director of QA/RA.
Must be able to track error outcomes to
_ensure strong regulatory compliance

Report weekly/monthly to Director of QA/RA.
Report Emergency Situations Immediately.
Adhere to all company policies, procedures and safety rules as stated in the Employee Handbook and otherwise posted or communicated.
Maintain consistent communication with QA managerial team and/or Director of QA/RA to provide all necessary information regarding the center or requested information from corporate office.
Maintain constant interaction with Center Quality Managers and Training Manager to ensure the center is quality oriented and prepared to successfully pass all audits.

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Must be able to balance competing priorities and adherence to quality standards
:

Any other duties as assigned.

REQUIREMENTS

High School Diploma or Equivalent. Associate's degree preferred.
Oneyear experience in a donor center with similar Quality Assurance or medical field experience or equivalent combination or education, training, and experience preferred.
Organizational and communication skills required.
Organized and have Computer skills including proficient in Microsoft Office.
Demonstrate spreadsheet and database computer skills.

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Must be able to work independently and multi-task effectively
:

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May require travel up to 60%:

Excellent customer service skills
Excellent team player and ability to work with others
Strong leadership abilities

PHYSICAL DEMANDS

Performing the responsibilities of the job requires close vision, distant vision, peripheral vision, depth perception, and ability to adjust visual focus.

Ability to communicate effectively, stand or sit, reach with arms and hands, use hands or fingers to handle or feel.

Ability to move physical records for review, up to 10 pounds, read and review documents for up to eight (8) hours at a time, and type at a computer for up to - 3 hours at a time.

WORK ENVIRONMENT
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May be exposed to bloodborne pathogens and other conditions common to a donor center. Work in a walk-in freezer for short intervals of time (-20C or colder).