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Sr. Quality Assurance Specialist

Sr. Quality Assurance Specialist

The Sr. Quality Assurance Specialist provides support to the Quality Assurance Department by performing duties that assure compliance with FDA/EMA and other applicable GMP regulations. The Sr. Quality Assurance Specialist performs quality activities in support of RedHill product disposition.  The Sr. Quality Assurance Specialist is responsible for quality and disposition activities in accordance with RedHill policies, standards, procedures and cGMP. Functional responsibilities include reviewing manufacturing related documentation such as manufacturing batch records, change controls, deviations, and other documents as applicable, and performing product release.

This position is in our Raleigh, NC office. 

MINIMUM QUALIFICATIONS:

Bachelor’s degree in a science-related discipline, with fundamental focus in biology, chemistry, biochemistry, microbiology, cell biology, and/or biotechnology is preferred, or equivalent combination of education, training, and experience. A minimum of 6 years of relevant and current work experience in pharmaceutical industry. Strong understanding of Quality System programs. Demonstrated analytical skills to lead investigations of quality issues and justify CAPA with appropriate documentation. Demonstrated knowledge of global regulations (i.e. ICH guidance, FDA/EMA GMP regulations and etc.) for manufacturing, packaging, and distributing active pharmaceutical ingredients and finished drug products. Direct experience reviewing and/or authoring standard operating procedures.  Excellent communication skills and abilities to collaborate with and present to individuals of varying levels of authority. Ability to expresses self clearly and concisely to key stakeholders; document issues and/or concerns concisely and comprehensively; adjust style, language and/or terminology appropriate for the audience. Travel of up to 15% may be required. 

PRINCIPAL RESPONSIBILITIES:

Conducts batch record review of batches of drug substance, drug product and packaging/labeling. Provides input on product disposition.

Interfaces with contract manufacturers and testing laboratories to communicate and resolve quality issues. May represent QA on assigned project and development product teams. Prepare reports and tracks and reports performance metrics.

Perform Document Review (SOPs, supporting batch record documentation, deviations, complaints, temperature excursions, retest/use-by dating). Notifies senior management regarding quality issues as required by RedHill procedures and prepared reports as requested. Tracks and reports performance metrics.

Implements and maintains activities for development batch record review, SOP review, temperature excursions, dating extensions, complaints handling, document archival, in compliance with cGMPs, SOPs, GDP, and in accordance with corporate, regulatory, and project timeline expectations.

Communicates with outsourced manufacturing, packaging/labeling and/or testing service providers regarding QA issues.

Proactively communicates, works with and provides timelines services to staff and colleagues in QA/QC, R&D, Supply Chain, Information Systems, and other groups as needed.

Ensures that all in-process and final product dispositioning activities are conducted in accordance with quality requirements.

Ensures that all documentation practices are performed to meet production needs and are in accordance with quality requirements.

Ensures all deviations and change controls are appropriately documented and investigated following QS program procedures and guidelines.

Review and/or author standard operating procedures and partner with operations on product-related investigations and deviations.

Review and approve Change Control, CAPAs, and Deviations.

Lead investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner.

Representation of the department and RedHill on cross-functional project teams and external business partner meetings.

Supports regulatory authority inspections and leads inspection readiness efforts.

Performs other related duties as assigned.

 

If you are interested in applying for an Open Position, please follow the directions below: 

  1. Submit your resume to redhillemployment@redhillus.com

  2. In the subject line put the full job title of the position you are applying for (including city), your name and the date of your submission. Note that we will only consider applicants that specify the Open Position that they are applying for.

  3. Cover letters are optional.


We offer a Comprehensive Benefits package that includes:

  • Medical, Dental, and Vision Coverage
  • Domestic Partner Coverage
  • Life Insurance
  • Short-Term and Long-Term Disability
  • Flexible Spending Accounts (Healthcare and Dependent Care)
  • Employee Assistance Plan
  • 401(k)

Job Applicants should be aware of job offer scams that are committed though the use of the internet and social media platforms. All legitimate correspondence from a RedHill Biopharma employee will come from a “@redhillus.com” or “@redhillbio.com” email address.