Specialist Quality Control - Holly Springs, United States - Ronin Staffing, LLC

Description

Job Description

HERE'S THE JOB DESCRIPTION:
Title: Specialist Quality Control #12723
Pay Rate: up to $40.50/hr
Location: Holly Springs, NC 27450
Length: 1 year contract + possible extension

Summary:
The Quality Control Specialist will be supporting the Quality Control Organization. The environment is challenging, fast-paced and ever-changing with varying degrees of process definition, but very rewarding for those who like hands-on science and want to make meaningful improvements in the QC space

Top Must Have Skills:

• Experience owning Quality Records (Deviations/Change Controls)
• Experience managing Stability Programs/Studies
• Experience establishing/maintaining processes and procedures for sample handling and storage
• Experience with managing quality records
• Technical writing is a huge plus

Responsibilities:

• Responsibilities will include sample management and stability lab set up, writing procedures and reports and supporting lab analysts with initial lab equipment installation, qualification, and validation.
• 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, technical assessments, microorganism assessments.
• Assisting with procurement activities for consumables and critical reagents for lab start up.
• Assisting with Quality Records as needed to (OOS/OOT/OOE/Non-conformances, Deviations, and Change Controls) to support the QC lab start up/routine lab activities.

Basic Qualifications:

• Doctorate degree OR
• Master's degree and 3 years of related experience OR
• Bachelor's degree and 5 years of related experience OR
• Associate's degree and 10 years of related experience OR
• High school diploma / GED and 12 years of related experience

Preferred Qualifications:

• Knowledge of analytical methods commonly used in the quality testing of Pharmaceutical Biologics
• Theoretical and practical knowledge of applying and developing separation and mass spectrometric methods for characterizing biologics
• Proven record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journals
• Experience and knowledge of Data Integrity Requirements of QC Systems
• Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)
• Excellent problem-solving capabilities and attention to detail
• Experience of collaboration within and across functional areas and outstanding customer service focus
• Excellent written and verbal communication skills