Sr. QC Data Review Specialist - GMP , Chromatography

The Senior Quality 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 range of complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and process inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance-oriented training as necessary. The Sr. QC Data Review Specialist assists with the development of SOPs or other quality documents as needed. Business needs and deadlines will require the employee to perform work duties outside of standard work hours on occasion. On-Site Expectations 100% on-site position.

• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Performs data review approval of documents, all types of data, protocols and/or reports.
• Performs complex quality control floor audits and/or floor inspections.
• Provides quality control evaluation and review of support materials, products, equipment and facilities as required.
• Assists with lab and data review improvement initiatives as needed.
• Assists with development/writing of SOPs and other quality control data review documents and/or reports as needed.
• Provides consultation on quality control data review and compliance topics in areas of expertise.
• Provides training in quality control data review and compliance topics in areas of expertise.
• Serves as client quality liaison and/or host of client audits; coordinates responses to client audits.
• Maintains accurate files and records.
• Serves as an effective member of the Quality Control Data Review team and may serve as a mentor to other
• Quality Data Review and laboratory employees in the area of expertise.
• Complies with company polices and SOPs.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

• Bachelor’s degree in Chemistry, Biology, or related field with 5+ years GMP related experience; OR Master’s degree in related field with 1+ years related experience; OR equivalent education and work experience.
• Chromatography experience required.
• Method validation experience preferred.

Knowledge, Skills, and Abilities

• 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 act independently.
• Ability to interact well with employees at all levels.
• Ability to host audits.
• Proficiency with Microsoft Office products.

Travel Expectations

• Up to 5% domestic travel required.

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 track record.