QC Data Review Specialist

Hello Professionals,We have an immediate opening with one of our clients. If you're interested, please take a look and send your resume to sonali@intellectt.comRole :QC Data Review SpecialistLocation: Milford, MADuration:6+monthsJob SummaryWe are seeking a highly motivated and detail-oriented QC Data Reviewer to join our team. The ideal candidate will have a strong background in cGMP analytical laboratory procedures and equipment, including HPLC, PA800, and SDS Page. This role requires a thorough understanding of quality control practices and data integrity in a regulated laboratory environment. The QC Data Reviewer will be responsible for the review and approval of analytical data, ensuring compliance with internal and customer specifications, SOPs, and established standards.Key ResponsibilitiesProvide support for product release processes, ensuring that deadlines are achieved.Review and approve cGMP-compliant analytical data, ensuring results align with internal and client standards, SOPs, and established protocols for data quality and precision.Make day-to-day decisions regarding data quality based on biochemical expertise and compliance knowledge.Collaborate effectively with Quality Control (QC) team members and cross-functional departments to promptly address and resolve quality-related issues, ensuring project objectives are met.Actively support data integrity initiatives, aiming for first-time accuracy.Contribute to the creation of metrics for tracking trends and reporting, including stability and QC analytical data.Analyze complex issues where the evaluation of data requires assessing various identifiable factors.Work closely with the Data Review team to identify and resolve any issues encountered.Mentor and assist new QC hires on cGMP and Good Documentation Practices (GDP).Assist in onboarding and re-training QC laboratory staff as needed, offering guidance and support.Participate in the review of Laboratory Investigation Reports (LIRs).Draft, revise, and develop Standard Operating Procedures (SOPs) and test forms as required.Possess extensive knowledge of QC analytical instruments and software.Exhibit strong task and team orientation, analytical capabilities, organizational skills, attention to detail, self-motivation, and an ability to manage multiple tasks simultaneously.Demonstrate exceptional communication and interpersonal skills.Exhibit strong communication skills, both written and verbal.Effectively manage workload to meet stringent deadlines.Provide timely updates to management when requested.Proficient with Microsoft Outlook, Word, Excel, PowerPoint, and other digital systems.Perform other assigned duties as needed.QualificationsBachelor's degree (B.S.) in Chemistry, Biology, Chemical Engineering, or a related biological science field.Proficiency with LIMS, EMPOWER, and QC analytical equipmentMinimum of 3+ years' experience in a cGMP analytical laboratory environment.Proficiency in HPLC, PA800, CS2500, SDS Page, and related analytical equipment.Experience with LIMS and EMPOWER software.Strong written and verbal communication skills.Ability to work collaboratively in a team environment and independently with minimal supervision.Attention to detail and ability to multitask in a fast-paced, high-demand environment.Task-oriented, organized, and self-motivated with strong problem-solving skills.Sonali Kumari Roy | Talent Acquisition SpecialistIntellectt INC732 979 2751 Ext: 580sonali@intellectt.com intellectt.com/517 Route 1 South, Suite 1115 Iselin, NJ 08830,If you prefer not to receive further communications from us, kindly click :UNSUBSCRIBE