Quality Assurance Associate

ECLARO; Chapel Hill (NC); On-site; USD 58,000 - 74,000; Full time

Benefits offered by this job

401k Retirement Savings Plan

Commuter Check Pretax Benefits

Medical, Dental & Vision Insurance

Job summary

ECLARO is seeking a Quality Assurance Associate for its client, a notable public research university in Chapel Hill, NC. This role supports QA systems, manages document control, and helps track quality metrics to improve processes.

Responsibilities include reviewing batch records, investigating deviations, and assisting in policy documentation. MasterControl experience is beneficial; position offers competitive benefits and on-site work.

Qualifications

• Experience with QA systems and document control processes.
• Familiarity with quality metrics and batch records would be beneficial.
• Ability to support training and maintain quality electronic systems.

Responsibilities

• Support QA Systems in collaboration with Quality Assurance Manager.
• Manage document control system and ensure updated records.
• Review batch records and identify corrections or deviations.
• Track QA progress using audits or metrics for KPIs.
• Assist in deviations investigations and CAPA planning.
• Support electronic quality management system usage and policies.

Skills

MasterControl

QA processes

Tools

MasterControl

Job description

Job Number: 26-01038

Be at the forefront of innovation. ECLARO is looking for a Quality Assurance Associate for our client in Chapel Hill, NC. ECLARO’s client is a notable public research university. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview

The person in this position will be responsible for supporting QA Systems in conjunction with the Quality Assurance Manager.

Responsibilities

• This person provides direction on the execution of quality processes for ACT facility employees, providing guidance and expectations on how those systems are to be followed.
• This person will help manage the critical document control system.
• Ensuring all facility documents are revised, made effective, and archived in a controlled manner according to appropriate governing policies.
• The person will also track QA System progress either through internal auditing or the use of metrics.
• Person will help direct others who are executing validation work, review executed work, ensure work is completed against plan.
• Person will be responsible for the review of executed batch records, identify corrections, and help resolve issues.
• Based upon QA system usage the person will investigate occurrences and deviations and identify potential corrective and preventive actions to improve processes.
• This person will support the use of electronic quality management system.
• Batch Record Issuance:
  • Assists in the process of creating batch records and forms needed to support the process.
• Batch Review:
  • Completes initial review of batch records.
• Initiates and investigates deviations related to the manufacturing and release of products.
• Responsible for tracking and trending manufacturing errors and other metrics for KPIs.
• Support Material Release, inspecting incoming materials and ensuring they meet specifications for use within manufacturing.
• Technical Writer and resource for policies, Standard Operating Procedures, forms, worksheets, and job aids in support of quality and manufacturing operations.
  • Assists and supports manufacturing in identifying needed policies, Standard Operating Procedures, and other required documents.
• Be a liaison for manufacturing to support projects.
• Maintain annual competencies in required quality functions and remain up to date in required EHS LMS modules.
• Assist in training other QA / QC members in ACT Quality Systems.
• Assist in the maintenance of quality electronic systems.
• Participate in 5 hours of continuing education annually in cellular therapy or quality topics.
• Responsibilities may be modified or added as needed and discussed with the QA Manager and / or Directors.

Skills

• Experience with MasterControl is beneficial.

Pay Rate

$33.65 / Hour

Benefits

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO

Contact Information

Carlo Flores

Email: [e-mail]

Phone: [phone]

Carlo Flores | LinkedIn

Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.