Quality Assurance Compliance Specialist

4 days ago

Reston, Virginia, United States INCOG BioPharma Services Full time

Quality Assurance Compliance Specialist

INCOG BioPharma Services in Indianapolis, IN is seeking a highly motivated individual and detail-oriented Quality Assurance Compliance Specialist to help implement Quality procedures and standards throughout the stages of drug product manufacturing, packaging, and release.

Working closely with the Sr. Quality Engineering Validation Manager, the Quality Assurance Compliance Specialist will be instrumental in ensuring site compliance with Regulations, Industry Standards (e.g. ISO), and organizational SOPs. They will also be key in championing and developing the organization's Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery.

The Quality Assurance Compliance Specialist will provide support with identifying and closing Operational and Quality gaps. They will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners.

The Quality Assurance Compliance Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. They will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills.

The Quality Assurance Compliance Specialist will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.

Key Responsibilities:

  • Perform primary generation and review of supplier | contractor evaluation documentation, including supplier evaluations, questionnaires, and audit reports.
  • Perform generation and review of quality agreements between suppliers and INCOG.
  • Perform review and approval of material specifications.
  • Provide oversight for shipping and receiving activities.
  • Perform internal audit planning and tracking of mitigations.
  • Ability to manage multiple projects in a fast-paced environment.
  • Provide support during normal hours (8 AM – 5 PM Monday-Friday) and after business hours as needed.

Requirements:

  • Bachelor's Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.).
  • Minimum of 5 years of biopharma industry experience with increasing responsibilities in supplier quality management and/or supply chain quality.
  • Excellent written and verbal communication skills.
  • General computer skills evidenced by hands-on work with computerized Operations equipment (SAP); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).
  • Experience with executing or providing oversight for supplier qualification activities for FDA/EMA regulated aseptic manufacturing facilities.
  • Experience with performing audits of internal and external sites/functions.
  • Certified Quality Auditor, or equivalent.

Why INCOG BioPharma Services?

  • Paid time off, based on tenure.
  • 11 paid holidays.
  • 401(k) plan with company match up, vested immediately.
  • Choice of health & wellness plans.
  • FSA and HSA options.
  • Onsite wellness facility.
  • Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations.

At INCOG BioPharma Services, we value equality and diversity in employment and oppose all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

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