The Quality Assurance Specialists primary responsibility will be to support quality systems as they relate to the manufacturing and testing of cGMP drug products. These duties will include, but not limited to: providing general support for Raw Material Release, Finished Product Batch Record Review, manufacturing documentation reviews, reviews of other documentation and quality records, and supporting the Quality Management System.
QA/QC professional with a minimum of 1-5 years experience within a pharma, biopharma and/or biotech manufacturing environment (including aseptic filling environment). Must have strong interpersonal skills and be a team player. The person also must be able to communicate professionally with clients and regulatory agencies. DEA experience is a plus.
- Maintain quality management systems for the aseptic filling process.
- Create, revision, and approve Standard Operating Procedures, Forms, Logs, or Policies.
- Establish and maintain good technique with regards to working in an aseptic environment.
- Perform weekly reviews on quality and manufacturing documentation.
- Perform QA review for Raw Materials (components and API’s), In Process, and Finished Products testing results.
- Review and approve manufacturing batch records.
- Manage specific QA systems such as, CAPA’s, Deviations, Environmental Investigation Reports, and Laboratory Investigation Reports
- Provide QA support during production preparation and aseptic filling operations.
- Perform all job responsibilities in compliance with cGMPs, company SOP’s, and current industry practice.
- Provide back-up support for the review and approval of Quality Assurance required signatures for controlled documentation.
- Open to a flexible and fluid work environment. Work on any assignment as directed
- Ability to interpret and relate Quality standards for implementation and review
- Proficiency in both written and verbal communication and presentations
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment
- Results oriented with sense of urgency
- Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged
- Ability to work with a diverse customer base
- Ability to work well in a cross functional team environment
- Must have proficient computer skills in Microsoft Word, Excel and Outlook
- BS or BA in Life Sciences or applicable relevant experience
If you would like to be considered, please submit your resume on our careers page.