OctaPharma Plasma Quality Assurance Supervisor in Houston, Texas

Requisition Number

17-3070

Post Date

10/11/2017

Title

Quality Assurance Supervisor

City

Houston

State

TX

Position Type

full-time

Description

Want to be a part of something exciting?

Help Octapharma Plasma open our next Donor Center right here in Houston, TX! At Octapharma Plasma you can channel your passion for helping others into a medical career that is fast-paced and personally and professionally rewarding.

We own and operate plasma collection centers throughout the United States. Our services are critical to the development

of life-saving patient therapies utilized by thousands of patients all over the world. Octapharma Plasma is a subsidiary of one of the world’s largest plasma products manufacturers, Octapharma AG, a Switzerland-based company that has been committed to patient

care and medical innovation for over 30 years. Octapharma employs over 5,000 people and has biopharmaceutical experience in 70 countries worldwide.

Quality – Regulatory - Operations

Job Responsibilities

We are seeking a Quality Assurance Supervisor to join our growing biopharmaceutical company and assist in opening our newest

Donor Center. Reporting into the Regional Director of Operations, this position is responsible for the overall quality program of the Donor Center. You will provide advice and consultation to other management team members regarding daily quality assurance

issues including donor suitability and/or product quality.

Additional responsibilities of the Quality Assurance Supervisor role include:

Determines if quality activities and manufacturing records are in compliance with SOPs and regulatory requirements; determines the need for corrective actions; ensures proper

documentation and determines effectiveness of the action

Performs final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications

Performs regular quality compliance audits of the center activities, i.e., manufacturing records, donor processing, plasma collection, product sampling, processing storage and

shipping

Provides direction and oversight of Quality staff ensuring required quality tasks are completed within required time frames

Identifies desired career path goals of the Quality staff and provides coaching and mentoring to aid the Quality staff in achievement of career goals

Prepares staff and co-hosts both internal and external audits

Collaborates with the Center Manager to complete all audit responses, ensuring that all audits are responded to and closed in required time frames

Ensures that monthly Quality and Safety meetings discussing SOP changes and regulatory requirements are conducted, documented and minutes are communicated to all center staff

Obtains certification as a Quality Trainer; responsible for training of center Quality Assurance staff

Analyzes tracking and trending data; determines appropriate actions to improve trending

Requirements

Quality – Regulatory - Operations

Job Requirements

Qualified candidates of this role must offer a Bachelor’s degree in an applicable field of study (or an equivalent combination

of education and experience may be considered). An ASQ certification is preferred. You must offer strong organizational skills, attention to detail and excellent interpersonal skills.

Other requirements of the Quality Assurance Supervisor role include:

Must have a minimum of one (1) year work experience in the biologics industry, preferably in a donor center, and a minimum of one (1) year quality assurance-related work experience

Supervisory experience preferred

Must possess knowledge and aptitude to learn various computer software; such as word processing, spreadsheets or other related software programs

Must have adequate communication skills and be able to effectively communicate with people at all levels

Must have ability to make decisions impacting the product and donor safety based on independent judgment and discretion

Quality – Regulatory - Operations

Benefits

At Octapharma Plasma we believe in our employees who have the passion and ability to make a difference to the quality

of life of their communities. The individual growth and success of each and every employee at Octapharma Plasma is an integral part of our continued growth and success. We offer competitive compensation and a comprehensive benefits package.

Other benefits include:

Medical, Dental and Vision Insurance

Life Insurance

401(k) contribution and matching program

Flexible Spending Accounts

Tuition Reimbursement

Team-oriented environment

Recognition programs