Quality Programs Associate

Employer
CSL Behring
Location
Boca Raton, Florida
Posted
Apr 22, 2021
Ref
R-132052
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

This position is responsible for collating and analyzing data for reporting Plasma Lookbacks and Biologic Product Deviation Reports (BPDRs) in an accurate and timely manner.

• A Lookback is the process of identifying and reporting units to a customer that were collected from a donor

who no longer meets applicable donation criteria.

• A BPDR is a report submitted to the Food & Drug Administration (FDA), to report certain events that may

affect the safety, purity or potency of plasma.

RESPONSIBILITIES

1 Work with applicable programs, such as LOGIC, eProgesa and Business Objects to generate and report accurate

Lookbacks.

2 Track incoming and outgoing notifications to ensure timely processing of Lookbacks and BPDRs per customer and

regulatory requirements.

3 Evaluate Plasma center information to determine appropriate Lookback time period based upon Standard Operating

Procedure (SOP) requirements. Research discrepant and/or missing information to determine the correct course of

action. Perform Quality Assurance (QA) review of all reports to provide accurate information to customers and the

FDA.

4 Provide guidance to center personnel on whether an event requires a Lookback and/or BPDR.

5 Communicate with customers, regulatory authorities, other departments, center and laboratory personnel to provide

and collect information regarding Lookbacks, BPDRs, and Recall Documentation, as well as to resolve problems.

6 Review and evaluate documentation to determine if the event is reportable to the FDA Center for Biologics

Evaluation and Research, (FDA-CBER) based upon defined criteria. Prepare, review and submit BPDRs for

Confirmed Viral Marker positive donors, Post Donation Information Reports (PDIRs), Error/Accident Reports, and

Medical Device deviations to the FDA.

7 Comply with Recall Documentation when requested by FDA Recall Coordinators. Documentation may include

customer acknowledgment and final disposition of the units reported to the final consignee(s), test results of units

involved, examples of product labels and any additional documentation the FDA might consider relevant to the

BPDR

8 File, fax, scan, copy and submit paperwork and report to centers and customers.

9 Collaborate with the review and update of department SOPs as needed.

10 Follow all Standard Operating Procedures (SOPs), company policies and procedures.

11 Maintain professional image and confidentiality of all company records and information at all times.

12 Perform other duties, as assigned, to support business needs.

JOB SPECIFICATIONS

Education

• High School diploma or equivalent combination of education, training and experience

Experience

• Minimum 1 year experience in related industry within a Regulatory Affairs or QA capacity preferred

• Understand regulatory standards, various local, state and federal laws that apply to the business

and where to find information on standards and interpretations

• Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent

interruptions, and shifting priorities in support of changing company objectives

• Establish solid working relationships to interface with and support senior management, third parties

and other positions and circumstances within the organization

• Strong customer service orientation with flexibility and adaptability to work as a member of the team

• Intermediate to strong working knowledge of Microsoft Office products

• Proven ability to work in a fast paced, dynamic environment

• Learn new processes and quickly engage in assignments to drive for action

Working

Conditions

(physical & mental requirements)

• Ability to make decisions which have significant impact on the department's creditability, operations

and services

• Ability to formulate complex and comprehensive materials such as authoritative reports of major

scope and impact, etc. and/or to make formal presentations

• Exercise good judgment to refer decisions to management when decisions fall out of the realm of

established guidelines

• Required to work overtime and extended hours

• Overnight travel required up to 10% of the time

• Frequent standing and walking

• Ability to lift or carry up to 25 lbs.

• 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.

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