Batch Record Quality Specialist

Request Code: Batch Record Quality Specialist
Desired Start Date: 4/15/2024
End Date: 3/16/2025
Hrs/Wk: 40.00
Location: Sanford, North Carolina
Rate Card Category 2: Level I (0-3 years)
Job Description: REPOST: 30394/30666 (Previously submitted candidates will automatically be disqualified.)
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
You will be a member of our dedicated and highly effective Manufacturing Quality Assurance team. You will evaluate and review manufacturing related activities in support of clinical and commercial batch production. Your expertise will help in identifying deviations from established standards, in the manufacturing of clinical and commercial batches. In the relevant cases you will approve change control activities to ensure compliance to procedures/GMPs.
As a Quality Assurance Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate explaining difficult issues and establishing consensus between teams.
It is your hard work and focus that will make us ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Contribute to Quality Assurance activities by performing manufacturing floor support, Batch Record review and other duties as assigned.
Independently assess production activities to determine potential Quality and Operational impact.
Suggest improvements and conduct continuous improvement activities.
Document deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
Maintain regulatory compliance in accordance with current Good Manufacturing Practices.
Provide Quality Review and oversight of site cGXP documentation related to the Sanford Production Operations and site activities to ensure compliance with global regulatory agencies and Client quality standards.
Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
Qualifications:
Must-Have
Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor's degree with at least three years of experience; OR a Master's degree with more than one year of experience.
Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.
Proactive approach and strong critical thinking skills.
Strong collaboration, relationship management and interpersonal skills.
Must be able to work in a team environment within own team and interdepartmental teams.
Excellent written and verbal communication.
Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener.
Effectively manages stressful situations, able to focus on task regardless of circumstances and stress induced pressure.
Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as SAP, Quality Tracking System (Trackwise), Veeva Vault, LIMS.
Nice-to-Have
Biology, Chemistry, Engineering, or related Technical Physical Science field of study preferred
Previous experience in Quality Assurance strongly preferred
Previous experience in QC, Manufacturing and/or Engineering strongly preferred
Skilled at the use of Enterprise systems including but not limited to site Quality Tracking System (QTS), Laboratory Information Management System (LIMS), SAP and document repositories
Interview:
Panel Via Teams
They would train on 1st shift for ~ 2 months, then move to 3rd shift.
Training 1st shift, M-F, 8:00a-5:00p
Third shift: 3rd shift hours will be 11:00p-7:30a (8 work hours, 30 min lunch) (No Shift Diff.) Work Environment: Onsite What will the resource be working with, or, have exposure to?: N/A
Will overtime be needed?: No If Yes, how many hours of overtime (on average) per week?: What is the minimum education experience required?: Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor's degree with at least three years of experience; OR a Master's degree with more than one year of experience.