Quality Associate - GMP in Durham, NC at Fast Switch

Date Posted: 11/16/2019

Job Snapshot

Job Description

Job ID: 54761

Our client in Durham, North Carolina is seeking a Quality Associate - GMP. 

Candidates who are eligible to work in the US without sponsorship are encouraged to apply.


Review of GMP raw data for compliance, review of GMP documentation, review of validation protocols (equipment, cleaning, and automation), review/approval of GMP procedures, identify gaps in existing Quality systems and propose solutions to site management. Assist in the development and implementation of Global Quality Systems, leading/supporting site and global initiatives, provides oversight with respect to the proper administration and adherence to all client policies and procedures; adherence to all regulatory licenses and regulations, interfacing with key Quality, Manufacturing, and Engineering customers, and coordination of investigations impacting the RTP site; performs review of GMP documents and raw data for compliance to applicable procedures as well as regulatory and corporate guidance documents. The Associate III QE may support internal and external inspections, assess and approve discrepancies from site, corporate, and regulatory guidance. The QE Associate III will also support the Manager for activities related to interviewing, hiring and training of employees, as well as compliance with training policies.
The Associate III of Quality Engineering will ensure that Quality systems within the Quality Assurance department remain in compliance with the client and industry cGMP standards. Additionally, the Associate III will ensure oversight and completion of all departmental milestones associated with clinical and commercial product manufacture. Failure to achieve results or erroneous decisions/recommendations may result in compliance issues, cause significant delays in schedules, cause financial repercussions, and/or may result in the re-allocation of additional, unplanned resources.

Principal Accountabilities:
• Facility, Utility, Equipment and Automation Validation review/approval of procedures, protocol/report approval.
• Review/approval of change control documents and activities associated with change control implementation
• Facility and equipment controls and release during shutdown, construction, product changeover.
• Provide cGMP guidance and quality support of Manufacturing on the floor issues with equipment or systems, including assistance with deviation initiation.
• Provide quality insight into Manufacturing Automations Systems lifecycle including: lifecycle process and documentation, computer systems validation, data integrity and system integration
• Oversight of site changeover program including: review of Changeover documentation, Carry-Over calculations, Summary Reports and equipment release.
• Review of PM work orders and CM work orders as applicable to cGMP systems
• Proactive identification and resolution of both technical and compliance issues/gaps
• Develops and implements aspects of various Quality Systems/System Improvements.
• Performs QA review of alarm assessments for cGMP equipment
• Supports internal and external inspections

• Demonstrated leadership capabilities.
• Strong oral and written communication skills; ability to communicate with management, peers and subordinates effectively.
• Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel
• Demonstrated problem solving skills
• Demonstrated troubleshooting and problem-solving skills.
• Knowledge of FDA/EMEA regulations and compliance.

Work Experience:
3+ years of Quality-related experience in the following disciplines:
• GMP review of validation documentation and strong knowledge of equipment/facilities/utility/automation systems
• Knowledge of FDA/EMEA regulations and compliance.
• Robust knowledge of current global Regulatory Quality requirements
• Regulatory Agency inspection experience
• Previous experience with Quality Systems oversight and development

Fast Switch, Ltd. is a high-growth IT staffing firm, with headquarters in Dublin, Ohio and with offices serving the Columbus, Detroit, Boston, Cincinnati, Minneapolis, Phoenix, Hartford, Los Angeles, Tucson, San Francisco, Denver, and Cleveland metropolitan areas.  We have a staff of over 780 associates and have experienced growth while remaining profitable.

Compensation can vary depending on experience and capability, plus benefits which include healthcare, dental, and vision insurance, long term disability coverage, and 401(k) with match and IMMEDIATE vesting.  Our benefits package, in this day and age, is superb.

To view all of our open positions, please go to: www.fastswitch.com and/or navigate to our Careers page.