The Quality Assurance Specialist supports the quality systems as they relate to the manufacturing and testing of cGMP drug products. Provide quality oversight for terminal sterilization, visual inspection, labeling and packaging Operations of parenteral drugs. Perform the quality release of incoming materials. Review documentation and quality records. Review and approve quality investigations.
QA/QC professional with a minimum of 1-2 years related work experience, preferably 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.
- Verify compliance with terminal sterilization, visual inspection, labeling and packaging operations documentation during operations
- Review and approve executed batch records and other associated controlled documents
- Perform QA review for stability and finished products testing results
- Perform QA review and material release for incoming materials
- Review and approve various quality investigations
- Perform tasks within specific quality systems such as, corrective and preventative actions, deviations, and laboratory investigation reports
- Understand and be able to perform job responsibilities in compliance with cGMPs, company stand operating procedures, 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
- Support Agency, customer and vendor audits as needed.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Open to a flexible and fluid work environment. Work on any assignment as directed.
- Must have strong interpersonal skills and be a team player
- Knowledge of quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment
- Ability to complete tasks with accuracy and efficiency
- Portrays appropriate levels of integrity and professionalism
- Ability to communicate effectively with management and staff
- Ability to interpret and relate quality standards into their review
- Ability to make decisions while assessing risks
- Ability to interpret and relate quality standards for implementation and review
- Energetic, self-motivated, organized
- Results oriented and efficient
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged
- Ability to work closely with a diverse customer base (internally and externally)
- 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.