Quality Assurance Associate - Technical
Cornerstone Therapeutics Inc. - Cary, NC

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Cornerstone Therapeutics Inc. is a specialty pharmaceutical company engaged in the development and commercialization of drugs for diseases that have unmet medical needs. We offer a unique and professional environment that values hard work, fosters creativity and promotes success. Headquartered in the Raleigh, NC area - our team consists of industry leaders and visionary employees who share our commitment to improving patient, care giver, and practitioner lives through bringing innovative medicines to market.

We value entrepreneurialism, motivation and a strong drive to succeed. The Company offers competitive wages, a strong benefit package which includes a 401(k) match, opportunities for performance-based bonuses and stock options.

Cornerstone Therapeutics is a growing company with strong values, an exciting vision and a clear strategy for the future. Our employees tell us we are a great company to work for - here's what we can offer you:

Challenging and interesting assignments
Supportive colleagues and a dynamic team
An environment where you are valued and initiative is encouraged

We currently have an opening for a Quality Assurance Associate - Technical position in the Cary, NC Corporate Office.

Purpose of Position: Provide quality support and oversight during the production, labeling, and packaging of APIs and/or Drug Product with the goal of ensuring safe and effective CRTX products reach the hands of the patient.

I. General Function/Specific Responsibilities:

  • Create and lead cross functional teams in quality investigation, root cause analysis, and development of action plans to resolve quality issues.
  • Manage all critical quality issues (deviations, recalls, APRs, stability failures, CAPAs, etc.).
  • Write, execute, troubleshoot, and close investigations in a timely manner.
  • Provide quality presence and input to Technical meetings with internal team and third parties.
  • Ensure all aspects of the handling, manufacturing, and distribution of pharmaceutical products are in compliance with effective Quality Agreements, that they meet relevant cGMP regulatory requirements and are conducted according to internal SOPs.
  • Establish good working relationships with clear communication and defined actions and goals.
  • Support internal/external audits as needed.
  • Approximately 10% travel required.

II. Requirements for Position:

  • Bachelor degree from accredited university with minimum 5 years work experience in related industry or equivalent. An emphasis on pharmaceutical manufacturing and Quality Control investigation experience preferred.
  • Experience in all areas of cGMP compliance, including FDA regulations.
  • Ability to work independently and in a team environment.
  • Excellent written and oral communication skills. This position will have direct contact with vendors and suppliers.

Only qualified candidates will be contacted.

Only responses containing salary requirements will be considered.

Cornerstone Therapeutics is an Equal Employment Opportunity employer.
No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.
This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.