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Sr. QA Specialist - Compliance

Macrogenics – Rockville, MD

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 assisting with administering the compliance programs at MacroGenics Inc. The individual will initiate, and review documentation associated with compliance such as vendor questionnaires, vendor audit reports, vendor audit responses, change notifications, and product complaints. The individual will audit and qualify vendors according to MacroGenics internal procedures and ensure qualification statuses for all vendors are current. The individual will also conduct internal audits of the Quality Assurance department. The individual will drive resolution to issues or concerns and communicate with quality assurance management and cross-functionally as necessary on a routine basis. This position will interface with various GMP departments such as quality control, manufacturing and supply chain on a frequent basis.
Responsibilities and Job Duties
  • Qualifies and maintains the qualification status of each contract manufacturer, contract testing laboratory, supplier and service provider.
  • Performs reviews, assessments and approvals of internal raw material and component specifications to ensure testing requirements align with regulations and industry expectations.
  • Releases raw materials for GMP manufacturing use and follows up with raw materials suppliers for outstanding issues that may prevent timely release.
  • Provides guidance to manufacturing and quality control staff for writing internal specifications to ensure that testing and material requirements will comply with US and EU regulations and guidance.
  • Conducts audits of contract manufacturing facilities, contract testing laboratories, suppliers and service providers and internal quality assurance to ensure compliance with EU and US regulations and guidance.
  • Participates on a cross-functional team focused on determining what went wrong, how to prevent the problem in the future, and determining whether the impacted product is suitable for release. Raises issues and concerns to management to decide how to proceed.
  • Prepares audit reports within the Master Control system and communicates any critical or major issues to QA Manager, QA Senior Director, Sr. Management and end users.
  • Monitors the corrective and preventive actions of contract manufactures, contract testing facilities and suppliers to ensure that deficiencies have been addressed and qualification status is maintained.
  • Provides current approved vendors list to purchasing on a routine basis to ensure that materials are only purchased from approved vendors
  • Communicates the discontinued use of a contractor or supplier when necessary and prevent use in the ERP system.
  • Maintains the current status of contactors or suppliers within the MasterControl System
  • Participates in performing Gap Analysis of MacroGenics GMP Quality Systems and presents findings to supervisor and senior management.
  • Coordinates the cross-functional assessments of contractor and supplier change notifications and participates in cross-functional assessment meetings.
  • Assists with maintaining the quality manual by ensuring that it reflects the quality system structure and policies.
  • Leads improvement initiatives for identified quality system gaps associated with compliance programs.
  • Applies regulations and current industry standards in order to make QA decision on complex issues associated with compliance programs.
  • May also coach, train and mentor lower level QA team members.

Qualifications

Education & Experience
  • High School Diploma and 15 years experience in the Biotech or Active Pharmaceutical Ingredient (API) Quality organization with escalating responsibility; or
  • BS degree in a scientific or technical discipline with minimum 8 years of experience in Quality Assurance in a life science GMP regulated manufacturing facility
  • Hands-on experience performing external quality audits
  • Hands-on experience writing comprehensive audit reports, and SOPs
  • Hands on experience communicating and resolving issues with contractors and suppliers
  • Hands on experience with disposition of raw material.
  • Prior experience in a commercial environment
Knowledge, Skills and Abilities
  • Demonstrated strong auditing skills
  • Demonstrated strong audit report writing skills
  • Must have excellent interpersonal skills
  • Must have excellent communication skills
  • Ability to influence others and drive cross functional collaboration
  • Ability to prioritize daily activities to meet internal and external customer needs in a fast-paced environment.
  • Must be able to travel up to 40%.
  • Proficient using MicroSoft Office, specifically with MicroSoft Word, Excel and Powerpoint

Supervisory ResponsibilitiesNone
Preferred Qualifications
  • American Society for Qualification (ASQ) certifications
  • Prior experience with Master Control

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.

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