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QA Specialist III/Sr. QA Specialist - Validation

QA Specialist III/Sr. QA Specialist - Validation

ID 
2017-1100
Category 
Quality Assurance
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

This position is responsible for reviewing, evaluating, and approving equipment, facility and utility related documentation such as validation protocols, change controls, out-of-tolerance reports, calibration and preventive maintenance records, repair work orders, SOPs, and for ensuring that GMP compliance has been met. This individual will be the point person for releasing all new systems into GMP use, and for withholding usage until requirements are met. The individual will drive resolution to issues or concerns, and communicate with the system owners on a routine basis. This position will interface with various GMP departments such as quality control, validation, facilities and manufacturing daily.

Responsibilities and Job Duties

  • Reviews master validation protocols for equipment, utilities and systems for appropriateness. 
  • Reviews executed validated protocols and associated data to ensure that the acceptance criteria were met and that the protocol was followed. 
  • Reviews repair work orders in the Blue Mountain system to determine if data is complete and if a change control is required. 
  • Reviews out-of-tolerance records in Blue Mountain and evaluates for accuracy and completeness. 
  • Reviews change controls in the MasterControl system to assess risk, impact, appropriateness and completion of action items.
  • Reviews and interprets complex data associated with validation, equipment, utilities and systems. 
  • Initiates quality events records in MasterControl (e.g. deviations, CAPAs, change controls) resulting from non-compliance of equipment/systems, SOPs and assigns to the responsible person as necessary. 
  • Releases GMP equipment/systems for use according to internal procedures when appropriate, and remove from use when necessary.
  • Reviews and evaluates interim validation reports associated with maintaining a validated state for equipment/systems. 
  • Performs internal system audits of critical utilities/systems and communicates findings to QA Director, Sr. Management and end users. 
  • Prepares audit reports and communicates any critical or major issues to QA Director, Sr. Management and end users. Move this one after the next bullet.
  • Analyzes quality event data for equipment/system on a periodic basis to identify trends and drive corrective and preventive actions to minimize repeat occurrences and ensures the corrective and preventive actions implemented were effective.
  • Collaborates with Quality Control, Validation, Facilities, and Manufacturing to resolve open issues related to equipment, utilities and systems.

Sr. QA Specialist will also perform the following responsibilities and duties:

  • Leads improvement initiatives for identified quality system gaps associated with equipment, system, utility and validation activities.
  • Applies regulations and current industry standards in order to make QA decision on complex issues associated with validation, equipment, utilities and systems.
  • May also coach, train and mentor lower level QA team members. 

Qualifications

Education & Credentials

 

QA Specialist III:
BS degree in a scientific, technical or engineering discipline with minimum 5 years of experience in Quality Assurance and/or Validation in a life science GMP regulated manufacturing facility.

 

Sr. QA Specialist:
BS degree in a scientific, technical or engineering discipline with minimum 8 years of experience in Quality Assurance and/or Validation in a life science GMP regulated manufacturing facility.

 

Experience

  • Hands-on experience executing utilities and equipment validation protocols.
  • Hands on experience reviewing and evaluating calibration and preventive maintenance records.
  • Hands-on experience reviewing and evaluating repair work orders.

Knowledge, Skills and Abilities

  • Demonstrated knowledge, understanding and application of regulations and current guidance documents associated with validation/qualification of GMP. 
  • Knowledge and understanding of change control concepts.
  • Ability to apply critical thinking to complex situations.
  • Ability to decipher complex technical data related to equipment, utilities or systems. 
  • Demonstrated knowledge and understanding of quality systems.
  • Knowledge and understanding of cleanroom utilities and HVAC units.
  • Must have excellent interpersonal skills.
  • Must have excellent written and communication skills.
  • Ability to prioritize daily activities to meet internal and external customer needs in a fast-paced environment.
  • Proficient using MicroSoft Office, specifically with MicroSoft Word, Excel and Powerpoint.

Supervisory Responsibilities:
No.

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.