Skip to content

Job Openings

Quality Control Specialist

Holly Springs, NC 27540

Posted: 01/23/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 617265 Is job remote?: No Country: United States

Job Description

Target PR Range: 30-40/hr
*Depending on experience

Hybrid - 4 days per week onsite

Ideal Candidate: Strong Empower knowledge required. B.S. and 5+ YOE. Understanding of UPLC & HPLC's.

be responsible for supporting the QC Chemistry team as the Business Process Owner (BPO) of the Empower computerized system and as a business subject matter expert for Chemistry methods. Responsibilities will include ownership of the Empower system including accountable for authorizing new accounts and account changes. They also conduct periodic non-privileged user access reviews. The Empower BPO is the site single point of contact responsible for the end-to-end process, including governance. They make decisions about how changes will impact the Empower system, manage related change controls, oversee system performance, own site related documents, metrics, exceptions, deviations, and continuous improvement. Writing procedures and reports, executing activities to support initial lab equipment installation, qualification, and validation. Method transfers and training development as well as support of implementation of computerized systems. The QC Chemistry BPO will initially report directly to the Director of Quality Control. This individual will be a subject matter expert on QC Chemistry Laboratory operations and testing. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary.

Day to Day:
Leading the QC Chemistry activities including system qualification and validation of Empower 3 FR5 and other upgrades.

Conduct training, troubleshooting, managing different aspects of Empower BPO role and attendance at meetings.

Assisting with review of validation documents to support UPLC, HPLC equipment and CE computerized systems.

Develop the Empower based method transfer plan.

Author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports, method assessments, and technical assessments.

Execute applicable BPO responsibilities: review/approval of Empower Template Qualification documents, unlocking channels and processing methods, increasing table space, locking/unlocking projects, maintaining user types/groups, maintaining project access

Assisting with procurement activities for consumables and critical reagents for lab start up.

Own and manage Deviation, CAPA and Change Control records to support Quality Control.

Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Holly Springs, NC

Ready to take the next step in your career? Explore job opportunities in the bustling area around Holly Springs, North Carolina, where growth awaits at every corner. Nestled in the heart of the Tar Heel State, Holly Springs offers a perfect blend of small-town charm and big-city amenities. From its vibrant arts scene at the Holly Springs Cultural Center to the mouthwatering Southern cuisine found at local favorites like the Mason Jar Tavern, this region has something for everyone. Boasting proximity to Raleigh, Durham, and Chapel Hill, as well as being a stone's throw away from attractions like the NC Museum of Art and PNC Arena, Holly Springs provides a unique and attractive environment for professionals looking to thrive. Dive into our job listings today and discover the endless opportunities this lively area has in store for you!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.