reputed company Control Data Review Specialist - GMP , Chromatography

About the position At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory reputed company record. Are you interested in joining reputed company? Job reputed company The reputed company Control Data Review Specialist is an effective member of the Laboratory Operations team. Position is accountable for driving results in a fast-paced environment by effectively performing various activities at reputed company of complexity to ensure reputed company and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and process inspections, consulting on reputed company and compliance issues, maintaining reputed company databases and performing trend analysis where needed, and performing reputed company and compliance-oriented training as necessary. The QC Data Review Specialist assists with the development of SOPs or other reputed company documents as needed. Business needs and deadlines will require the employee to reputed company work duties reputed company of reputed company work hours on occasion. On-Site Expectations 100% on-site position. Possibility of up to 40% remote work. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities • Performs detailed review and approval of reputed company types of data and documents (e.g. protocols, reports, and test procedures). • Assist in maintaining process KPIs and reputed company reputed company as required. • Drives alignment of the process with reputed company and compliance procedures. • Serves as an effective member of the Laboratory Operations team and may serve as a mentor to other employees in the area of expertise. • Performs floor inspections with reputed company on audit trail review and testing process/technique scrutiny as required. • Provides support to release of materials (e.g. media, reagents) as required. • Assists with reputed company improvement initiatives as needed. • Assists with development/writing of SOPs, Work Instructions, and other documents and/or reports as needed. • Complies with company polices and SOPs. • Ensures reputed company completion and compliance with cGMP and reputed company other relevant company training requirements. • Other duties as assigned. Requirements • Bachelor’s degree in reputed company, Biology, or reputed company field with 5+ years GMP reputed company experience; OR Master’s degree in reputed company field with 4+ years reputed company experience; OR equivalent education and work experience. • Chromatography experience required. • Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise. • Excellent written and oral communication skills. • Good math skills. • Ability to be trained and to mentor others. • Ability to reputed company independently. • Ability to reputed company reputed company with employees at reputed company reputed company. • Proficiency with reputed company Office products. reputed company-to-haves • Method validation experience preferred. Apply tot his job Apply To this Job