URGENTLY HIRING: Quality Analyst

Overview

Conduct QC inspections, manage CAPA/NCR, support GMP compliance in medical device/pharma

Key Responsibilities

• environmental monitoring
• quality control
• capa tracking
• batch release
• root cause
• regulatory audits

Tasks

-Develop, review, and release quarterly environmental monitoring trending reports, ensuring significant trends are brought to management attention. -Perform Quality Control activities at processing or distribution sites, including incoming material inspections, in-process inspections, and finished product inspections. -Coordinate and track CAPA, NCR, and Deviation records, ensuring tasks are completed on time. -Perform reviews of batch production records and manufacturing records as part of lot release activities. -Assist teams in problem-solving and root cause analysis for associated quality events. -Interface with colleagues to ensure effective corrective and preventive actions for recurring product/process discrepancies. -Provide Quality Management System Operations support to all CGMP departments. -Provide support related to gowning qualification and training. -Ensure timely issuance, review, and approval of Microbiology and environmental monitoring testing results. -Assist in hosting onsite regulatory audits and inspections. -Coordinate and track the site environmental monitoring testing program. -Assist in the review and approval of equipment qualifications. -Provide input based on knowledge and experience with batch release requirements. -Assist in the review of Calibration and Preventative Maintenance. -Maintain accurate and complete records of Quality Control activities, following Good Documentation Practices.

Requirements

• excel
• gmp
• fda
• bachelor's
• sops
• capa

What You Bring

-Experience with tissue and cells. -Proficiency in Microsoft Excel. -Knowledge in biology, human tissue, skin processing. -Understanding of GMP compliance. -Bachelor's Degree in a Life Science discipline or related field. -0-2 years of relevant industry experience within Medical Device, Pharmaceutical, or Tissue commercial organization. -Experience in an FDA-regulated environment, particularly in medical device, human tissue, or pharmaceutical manufacturing. -Experience writing Standard Operating Procedures and Work Instructions. -Knowledge of Quality System elements for CAPA, Non-Conforming Reports, and Deviations.

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Benefits

-Medical, dental & vision -Health Spending Account (HSA) -Short and long-term disability -Critical Illness, Accident, and Hospital -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Transportation benefits -Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms

Interview Process

-phone interview scheduled after resume submission