HIRING! QA Lab Document Control Specialist - JD25

Job Description

Job Description

Job Title: Quality Assurance Associate
Location: Chapel Hill, NC (onsite)
Contract Duration: 1 year

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

• 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.
  

Added to JD:

• 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.

• Experience with MasterControl is beneficial.
• Responsibilities may be modified or added as needed and discussed with the QA Manager and/or Directors.

Company DescriptionTechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.

We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.

Company Description

TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. \r\n\r\nWe serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.