Batch Record Specialist
Posting ID: JP-002483268
I have a Batch Record Specialist opportunity available right now! This position can hold interviews as soon as possible and offers a competitive salary.
• Perform Quality review and final disposition of executed batch records.
• Review component release documentation and released Raw Material documentation for production use.
• Review QC Chemistry and Microbiology Certificates of Analysis for in-process and finished product test data for all products manufactured on site.
• Document retrieval from local files and archives as required for other departments.
• Facilitate in process audits and internal audits as needed.
• Work closely with QA functional teams to align and promote awareness on data integrity and good documentation practices.
• Report of weekly/monthly/quarterly metrics (Right the First time, Average Cycle Time, Error free and Success Rate) to Quality Management.
• Facilitate and coordinate with project teams to enhance, improve and streamline batch record cycle times.
• Attend and facilitate meetings as necessary.
• Navigate through various online platforms, including JDE, TrackWise, OSM and TraceLink.
• Facilitate and support online platform implementation including Veeva and BMRAM.
• Initiate investigations in Track Wise as necessary.
• Execution of CAPA’s and Effectiveness Reviews as required.
• Facilitate and provide data for Annual Product Reviews.
• Assist in inter-departmental training and provide compliance guidance to personnel.
• Routine interaction with other departments for purposes of collecting batch record information or working to resolve quality related issues.
Additional Skills & Qualifications:
• Bachelor’s Degree (BS or BA) in a science related filed (i.e. engineering, chemistry, biology).
• Minimum of 3 years’ demonstrated excellence in the pharmaceutical GMP industry.
• Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820) and other FDA regulations and guidance’s.
• Able to use personal computer and standard office equipment such as fax and copy machines, calculator, and printers. Aptitude to learn computer programs as needed (i.e. Word, Excel) in addition to other business applications.
• Strong verbal and written communication skills. Resourceful and well
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072