Antares Pharma: Making Medicines Feel Better

Quality Assurance Specialist

SUMMARY POSITION DESCRIPTION:

The Quality Assurance Specialist is responsible for administering and maintaining quality processes for Antares Pharma's development and commercial programs. This includes activities pertaining to development, deployment, administration and maintenance of integrated quality systems and operations encompassing development and commercial programs for Antares Pharma and its third-party vendors. The incumbent shall be capable of independently establishing short and long term objectives following strategic direction from Antares QA management utilizing sound judgement within broadly defined practices to achieve objective-driven results.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to:

  • Responsible for uniformly administering and monitoring all quality processes and assure conformance to applicable regulatory standards including, but not limited to, 21 CFR Parts 210, 211, 820 and 11, and applicable ICH Guidelines.
  • In association with product development programs, support establishment of product and process quality requirements and standards, including but not limited to Critical Quality Attributes (CQA), Critical Process Parameters (CPP), Critical Control Points (CCP), Specifications and Capabilities.
  • Establish and implement quality surveillance tools, programs and plans to assure the Company's development and manufacturing operations achieve and maintain compliance with applicable regulatory standards.
  • Maintain policies, standards, procedures and guidelines to align with the Company's quality systems and facilitate their deployment.
  • Analyze and improve quality systems and processes, and ensure ongoing compliance with applicable regulatory requirements.
  • Support quality processes including Product Quality Complaint Management, Recalls/Withdrawals, Regulatory Reporting, Deviation Management, Investigations, CAPA and Change Management, ensuring timely completion and efficient resolution of all atypical/con-conforming conditions identified.
  • Serve as interface with Vendors to monitor product manufacturing and control processes, review records, resolve quality departures, non-conformances and atypical events, and disposition materials, components and products.
  • Conduct risk assessments and develop risk management plans for product design, specification development and establishment of processes supporting new products, major modifications and line extensions.
  • Implement continuous improvement initiatives including implementing Quality-by-Design (QbD) principles and procedures for future development programs.
  • Support development of sampling and inspection plans for commercial products and products undergoing development.
  • Support and monitor development and execution of qualification and validation studies.
  • Develop procedures and methods for evaluating and inspecting products and processes.
  • Facilitate gathering of data and information for use in the generation of periodic performance metrics.
  • As assigned, support execution of GCP and GLP surveillance activities for non-clinical and clinical projects.
  • Conduct training exercises commensurate with area(s) of functional expertise.
  • Support facilitation of audits and inspection administered by health authorities, third-parties and partners as assigned by manager.
  • Other activities as assigned by departmental management.

EDUCATIONAL REQUIREMENTS(degree, license, certification:

  • BA/BS degree in a science or related field. ASQ Certification preferred.

YEARS OF EXPERIENCE:

The candidate will possess broad experience within the Quality function combining excellent technical expertise and strong cross-functional communications skills. The individual should have three (3) to five (5) years of direct experience in the pharmaceutical, and combination product and/or medical device quality assurance function.

OTHER SKILLS AND ABILITIES:

  • The candidate will be a problem-solver with the ability to exercise sound judgment under challenging circumstances.
  • Excellent communication skills with the ability to effectively promote intra-and inter-organizational cooperation.
  • In-depth knowledge of GXP, 21CFR, EU GMP, ICH, ISO, QSR and other applicable Regulations, Standards, Directives and Guidance with hands-on experience in their interpretation and application to ensure compliance through practical and progressive approaches is achieved and maintained.
  • Possessing strong character with self-confidence and integrity necessary to ensure that the best-interests of product recipients and customers are always of first and foremost importance.
  • Strong background in a manufacturing and operations environment preferably supporting aseptically -produced pharmaceutical products and drug-device combination products.
  • Experience working within vertically-integrated and virtually-structured settings for small- to mid-sized organizations is preferred.
  • Sound technical background and the ability to educate stakeholders, management and customers pertaining to quality assurance/control principles and techniques.
  • Experience working with electronic documentation systems (e.g. MasterControl)
  • Ability to interface with internal customers at all levels and 3rd-party partners.
  • Strong negotiation and de-conflicting skills.
  • Ability to travel domestically and internationally.

 APPLY TO: Careers@Antarespharma.com

Antares Pharma, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

*****We are not accepting solicitations from Recruiters or Consultants at this time.

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