Quality Control Data Review Specialist - Weekend 1st Shift

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 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. Business needs and deadlines may require working outside of standard work hours on occasion.

100% on-site position. 1st Shift: Saturday - Monday, 7:00am - 7:30pm.

Responsibilities

• Performs detailed review and approval of all types of data and documents (e.g., protocols, reports, and test procedures).
• Assists in maintaining process KPIs and quality metrics as required.
• Drives alignment of the process with quality and compliance procedures.
• Serves as an effective member of the Laboratory Operations team and may mentor other employees in areas of expertise.
• Performs floor inspections with a focus on audit trail review and testing process/technique scrutiny as required.
• Provides support for the release of materials (e.g., media, reagents) as required.
• Assists with continued improvement initiatives as needed.
• Assists with the development/writing of SOPs, Work Instructions, and other documents and/or reports as needed.
• 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 2+ years of GMP-related experience; OR
• Master’s degree in a related field with 1+ years of related experience; OR
• Equivalent education and work experience.
• Chromatography experience required.
• Method validation experience preferred.

Skills

• Strong knowledge of regulations and SOPs applicable to the area of responsibility and stays updated on new regulations and regulatory guidance.
• 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

1st Shift: Saturday - Monday, 7:00am - 7:30pm.

Travel Expectations

Up to 5% domestic travel.

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.

• Regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear; and smell.
• Frequently required to stand.
• Occasionally required to walk; sit; stoop, kneel, crouch, or crawl.
• 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 include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Frequently exposed to moving mechanical parts and risk of electrical shock, burn hazards, and microbial contamination.
• Occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and vibration.
• The noise level in the work environment is usually moderate.
• Required to wear appropriate personal protective equipment (PPE) for specific job duties, which may include safety eyewear, respirators, lab coats, full protective body coverings, and gloves.