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Featured in CNBC, Digital Journal, Fox News & CIO Review GBSI has been successfully serving the world’s top Fortune 500 organizations for the last 19+ years. GBSI IT teams and consultants have delivered more than 568 projects successfully within the automotive, manufacturing, retail & pharmaceutical domains across the world. Headquartered in Moline, IL GBSI’s clients and consultants are spread across the US, Canada, Europe & India. Join us to be a part of an ever growing, elite IT team & start building your dream career today!

To be a successful Quality Product Release Specialist will embody GBSI's core employee characteristics of being passionate about IT, taking full ownership of your work & having a growth mindset. Additionally, you will exhibit strategic vision, thoughtful engagement, strong analytical/process skills, a bias for action, and the ability to partner with senior operational leaders.

Position Description / Skill Set Required:
The Quality Product Release Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. Execution of the activities and responsibilities related to this position are designed to further develop the knowledge and skill foundation required to advance to other Quality-based functions within the organization.
The Quality Product Release Specialist, with guidance from the IPT Quality Release Lead, ensures product / process quality, performs activities to facilitate the release of product to the marketplace, and ensures proper control of material.
The Quality Product Release Specialist is knowledgeable in federal and other regulatory agency requirements and cGMPs to ensure that all areas are in compliance and will train on and gain competency in activities to ensure quality and compliance of product manufactured by the functional area. Specific responsibilities include but are not limited to the following:

1. Becomes fully trained in Quality SOPs, production SOPs as needed, and SAP functions as required by Quality Specialists.
2. Learns cGMPs, the manufacturing process, and quality systems.
3. Responsible for the review and release of filled container batches destined for both domestic and international markets.
4. Prepares and submits release protocols. Prepares CoAs to support regulatory filings.
5. Works cross-functionally to resolve outstanding issues from the manufacture or testing of the batch (e.g., batch record review, investigations, testing, CRs, etc.) to ensure the timely submission/release of the material.
6. Ensures compliance with departmental procedures.
7. Actively participates in the Tier process and uses this forum to escalate concerns and best practices.
8. Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
9. Ensure proper identification of release status and control of materials through maintenance of batch and stock status in SAP and through physical tagging of material, as required.
10. Assists with training of new team members.
11. Cross trains to support other functional quality areas, including but not limited to deviation management, environmental monitoring investigations, and inspection support.

Required Experience and Skills:

• A minimum of four years of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality or Operations.
• Evidence of leadership skills coupled with good oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
• Effectiveness and creativity in approaching and solving technical problems.
• Attention to detail, flexibility and an awareness of production and quality control problems.
• Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
• Basic understanding of the use and maintenance for Microsoft applications (such as MS Excel, MS Outlook, and/or MS Word)

Preferred Experience and Skills:

• Familiarity with vaccine and/or pharmaceutical processing.
• Familiarity with batch dispositioning (release) activities is a strongly preferred skill necessary for success in this position; prior batch disposition experience is a plus.

Education Minimum Requirement: Bachelor’s degree. Technical emphasis in an appropriate Scientific or Engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience.

 

Location Preference:

• Durham, NC

Apply today to join us as part of an elite IT team & let GBSI help you build the career of your dreams!

We are excited for your growth!

Equal Employment Opportunity Statement

GeniusBSI is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation.

All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.