Sr. QC Data Review Specialist - GMP , Chromatography

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.

About the role

The Senior Quality Control Data Review Specialist is an effective member of the Laboratory Operations team. This position is accountable for driving results in a fast-paced environment by performing various activities at a 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, performing trend analysis, and delivering quality and compliance-oriented training. The role also assists with the development of SOPs or other quality documents as needed. Business needs and deadlines may require occasional work outside of standard hours.

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.
• 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 mentor other Quality Data Review and laboratory employees.
• Complies with company policies and SOPs.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Requirements

• 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.

Skills

• 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.

Schedule

100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Travel Expectations

Up to 5% domestic travel required.

Physical Demands and Work Environment

The physical demands 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 is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell.
• The employee is frequently required to stand.
• The employee is occasionally required to walk; sit and stoop, kneel, crouch, or crawl.
• The employee must 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, color vision, peripheral vision, depth perception, and ability to adjust focus.
• While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock, burn hazards, and microbial contamination.
• The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and vibration.
• The noise level in the work environment is usually moderate.
• The employee will be required to wear appropriate personal protective equipment for specific job duties, which may include safety eyewear, respirators/breathing apparatus, lab coats, full protective body coverings, and various types of gloves.