Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges. We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing.
RCA is currently recruiting for a Senoir Quality Assurance Specialist, Client and Project Support for a Pharmaceutical Manufacturing client. This work must be conducted oniste at the client location in Michigan. This is a 6 month, 40hrs/week consulting opportunity.
The Sr. QA Specialist provides quality support and quality expertise 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.
Duties and Responsibilities
- Provide support and guidance to Quality Specialists of various levels. Responsibilities include coaching and mentoring in focused quality areas, as directed by quality management.
- Provide quality expertise to project teams to ensure that project deliverables meet all regulatory and industry best practice standards and project schedules, requirements and deliverables, and ensuring project-related tasks assigned are delivered according to project schedules.
- Provide sound quality and technical inputs to the Change Management process and process owners to ensure all project-related deliverables are aligned with and delivered according to change plans and implementation requirements.
- Independently support, as a Quality Lead, implementation of internal continuous improvement projects.
- Perform Quality Assurance review and approval of all cGMP documentation in support of both GRAM and client-driven projects, including: Procedures, Test Methods, Master Batch Records, Risk Assessment Reports, Validation Documents (master plans, protocols, studies, summary reports, requirements documents, etc.)
- 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.
- Experience in pharmaceutical manufacturing of regulated products with an understanding of cGMP, FDA guidelines and multinational regulatory standards required.
- 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.
- Ability to complete tasks with accuracy and efficiency.
- Portray appropriate levels of integrity and professionalism.
Qualified candidates possess a proven track record of experience with with increasing levels of independence with regards to assigned project oversight. 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 8-10 years related work experience.
Diversity and inclusion programs at Regulatory Compliance Associations® (RCA) are strategically designed to attract, develop, and retain the industry’s most skilled and professionally talented individuals regardless of their race, sexual orientation, religion, age, gender, or disability status.