Provides quality direction to both internal and external projects, including the on-boarding of new clients / client projects. This position works closely with Project Managers, Filling and Finishing Operations, Technical Services, Validation, and QC Analytical and Microbiology departments.
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.
- Performing Quality Assurance review and approval of all cGMP documentation in support of both GRAM and client-driven projects, including:
- Raw Material, Component and Finished Product Specifications
- Test Methods
- Master Batch Records
- Risk Assessments
- Validation Documents including Analytical and Microbiology Test Method Validation, Equipment Qualification (IQ, OQ, PQ), PPQ, URS, FRS, etc.
- Working as the QA representative on project teams to ensure that project deliverables meet all regulatory and industry best practice standards.
- Perform all job responsibilities in compliance with cGMPs, company SOPs, 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.
- Project a positive and professional image of the GRAM and self by providing quality services to all internal and external customers.
- Perform all other tasks, projects, and duties as assigned.
- Experience and expertise in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is a must
- 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, works with a sense of urgency
- 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
- Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment
- Must have strong interpersonal skills, be a team player, have strong customer focus with a drive to exceed expectations.
- Ability to complete tasks with accuracy and efficiency
- Portrays appropriate levels of integrity and professionalism
BS or BA in Life Sciences or applicable relevant experience and a minimum of 3 years related work experience.
If you would like to be considered, please submit your resume on our careers page.