job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Focusing on immune diseases like HIV that affect a large percentage of the population, the work our longtime partner conducts is imperative to a better, healthier future. To be recognized as a crucial part to furthering this goal, join this growing team now!
location: Marietta, Pennsylvania
job type: Contract
salary: $29.19 - 34.34 per hour
work hours: 9 to 5
- Job Responsibilities
- The QA Systems Specialist is responsible for the oversight, monitoring, and reporting function to support quality systems that are used at Marietta facility to support production of vaccines. The Quality systems under the scope of this role include deviation system, change management system, CAPA system, customer complaints, Product Quality review, & Quality Management system. The QA Systems Specialist is responsible to ensure compliance with internal procedures, policies, standards, FDA regulations.
- Responsible for quality system process expertise and daily oversight activities for cGMP quality systems.
- Responsible for ensuring the Quality Systems LSOP/processes are robust and compliant with Regulatory and global requirements.
- Responsible for reporting and monitoring on cGMP quality systems, site KPIs, and other miscellaneous quality unit systems.
- Responsible for execution of training activities on cGMP quality Systems (Qualified Trainer)
- Responsible for acting as QA liaison with QA operations to site personal to resolve technical problems or provide quality system expertise to help provide solutions while still assuring compliance to cGMP.
- Responsible for acting as QA liaison with global support functions to resolve technical problems or provide quality system expertise to help provide solutions while still assuring compliance to cGMP
- Responsible for backup roles for Quality Systems Manager when applicable.
- Responsible for backup roles for documentation systems responsibilities within the quality systems disciplines (includes; procedures management, documentation control, archival & logbooks). This also supports any Records Champion responsibilities (i.e. lighten up)
- Lead quality systems improvement/simplification project and site initiatives as applicable.
- Complete all work with highest regard to quality and safety by ensuring compliance with GMPs, applicable EHS regulations, standard operating procedures, and industry practices
- Education & Qualifications
- BA/BS degree in sciences or business. Degree in other discipline if sufficient technical depth has been achieved by professional experience
Biology, Microbiology, Chemistry, Biochemistry, Business, Statistics
- 3-5 years pharmaceutical experience in a Quality Organization.
- Versed in GMP's, NIH Guidelines, FDA and other regulatory agency requirements for validation and operations, analytical and stability functions and compliance
- Experience with implementation in deviation management, CAPA, or change control, and verses in reporting and KPI functions
- Strong communication and problem solving skills with a demonstrated ability to work well with and influence others without direct reporting relationships
- Demonstrated ability to work well with and influence others without direct reporting relationships
- Problem solving skills
- Experience in managing process changes.
- Strong technical understanding of industry and science practices related to the business
- Relevant experience in industry and with hands-on experience working through situations and processes is necessary to apply and manage quality system activities
- A wide scope of industry experience allows for a more holistic view of potential impact areas and problem resolution.
- SAP Experience
- Experience in startup facility
- Experience with operational excellence concepts
- Experience in process design
skills: SOP, Quality Assurance, CAPA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.