The Quality Assurance (QA) Associate will have good manufacturing practices (GMPs), good clinical practices (GCPs) and/or good laboratory practices (GLPs), as well as an awareness of FDA Quality-related standards/guidance. The QA Associate will coordinate quality assurance programs, policies, processes, procedures and controls to ensure that the performance and quality of products, the conduct of clinical trial materials (CTM) manufacturing, and the pre-clinical GLP testing conform to established quality standards and agency guidelines.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide QA support during manufacturing and analytical operation including review of both master and executed manufacturing batch records.
- Provides input to Research and Development (R&D) entities to ensure that the products under development meet appropriate guidelines and FDA expectations and ensure that vendors are qualified appropriately based on the developmental phase.
- Assist all departments in the generation of quality system documentation; such as SOPs, deviation/investigation reports and change controls.
- Provides quality input as part of Soligenix project teams.
- Coordinates corporate technical change control process to ensure key GMP documents such as product specifications and analytical methods are appropriately controlled.
- Coordinate process and assist in quality investigations (including OOS investigations) and work with impacted functions in the development of required CAPA items.
- Provide assistance/support to key supplier/vendor management and oversight, including auditing.
- Actively participate in the generation and review of key regulatory submissions such as chemistry, manufacturing and controls sections of both INDs and NDAs.
- Maintains up to date Approved Supplier/Vendor list as well as internal and external auditing schedules.
- Coordinate deviation process and procedures.
- Lead quality oversight of stability program inclusive of data analysis.
- Leads audits/quality control verifications of key clinical/regulatory documents including IND and clinical trial applications submissions (as needed), clinical study reports, Investigator’s Brochure, etc.
EDUCATIONAL REQUIREMENTS (degree, license, certification):
- Minimum of BA/BS degree in Life Sciences/Chemistry
YEARS OF EXPERIENCE:
- At least 3 years of experience in a Quality Assurance role in the pharmaceutical industry.
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
OTHER SKILLS AND ABILITIES:
- An advanced attention to detail and excellent written communications skills are a must.
- Strong, professional interpersonal skills including ability to communicate effectively with people individually and in groups.
- Ability to communicate with technical and non-technical colleagues.
- Knowledge/awareness of FDA, EU GMP, GLP, ICH regulations and industry best practices.
- Knowledge/awareness of cGMPs, GCPs and/or GLPs and ICH Guidance.
- Knowledge of records and data management; best practices, tools and technology support systems.
- Experience with biologics and vaccines a plus.
How to Apply
Please provide resume, references, and current location via e-mail to email@example.com. Compensation will be commensurate with experience. No phone calls, please. No recruiters.