Quality Control Data Review Specialist - GMP , Chromatography

Alcami Corporation•Wilmington, NC

4d•Onsite

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 track record. Are you interested in joining our team? Job Summary The 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 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.

Requirements

Bachelor’s degree in Chemistry, Biology, or related field with 5+ years GMP related experience; OR Master’s degree in related field with 4+ years related 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 act independently.
Ability to interact well with employees at all levels.
Proficiency with Microsoft Office products.

Nice To Haves

Method validation experience preferred.

Responsibilities

Performs detailed review and approval of all types of data and documents (e.g. protocols, reports, and test procedures).
Assist in maintaining process KPIs and quality matrix as required.
Drives alignment of the process with quality 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 focus 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 continued 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 timely completion and compliance with cGMP and all other relevant company training requirements.
Other duties as assigned.