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 Microbiolog
ESSENTIAL DUTIES & RESPONSIBILITIES
- Perform a variety of tasks requiring some/minimal guidance from supervisor.
- Provide working knowledge of GMP and regulatory requirements as it relates to performing Quality Assurance review and approval of cGMP documentation in support of both GRAM and client-driven projects, including: SOPs, Raw Material, Component and Finished Product Specifications, Risk Assessments including change control assessments, Validation Documents including Analytical and Microbiology Test Method Validation, Equipment Qualification and Computer Software Validation (IQ, OQ, PQ), PPQ, URS, FRS, etc.
- Perform all job responsibilities in compliance with cGMPs, company SOPs, and current industry practice.
- Act as a QA representative on project teams to ensure that project deliverables meet all regulatory and industry best practice standards.
- Ensure project relates tasks assigned by supervisor are delivered according to project schedules.
- Provide back-up support for the review and approval of Quality Assurance required signatures for controlled documentation.
- Project a positive and professional image of GRAM and self by providing quality services to all internal and external customers.
- Understand and is aware of the quality consequences which may occur from the improper performance of assigned job.
- 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.
- Perform all other tasks, projects, and duties as assigned.
DESIRED SKILLS & ABILITIES
- Experience and expertise in aseptic environment is desired or manufacturing environment of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
- 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 individual 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 independently and in a cross-functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
- Ability to interpret and relate quality standards for implementation and review.
- Must have strong interpersonal skills, be a team player, have strong customer focus with a drive to exceed expectations.
- Portray appropriate levels of integrity and professionalism.
EDUCATION & PRIOR EXPERIENCE
- Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment
- This level of knowledge is normally acquired through completion of a Bachelor's Degree in Life Sciences or a related field and/or a minimum of 3-5 years related work experience.
GRAM supports Equal Opportunity Employment