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.

On-Site Expectations:

• Hybrid role with 3 days expected on-site.

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.

Qualifications:

• Bachelor’s degree in Chemistry, Biology, or related field with 2 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% travel required.

Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk, and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, or manufacturing areas for inspections or work discussions. The noise level in these additional work areas may be louder. The employee is required to wear the appropriate personal protective equipment to perform the job duties.