Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in Marietta, PA.
- 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 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.
Skills and Requirements:
- 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 working with deviation management, CAPA, or change control, and technical writing for data trending and trend reporting.
- Strong communication and problem-solving skills with the ability to listen to others and evaluate and communicate solutions.
- Demonstrated ability to work well with and influence others without direct reporting relationships, ability to work with a team.
- 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 with operational excellence concepts.
- Experience in process design
If you are having difficulty in applying or if you have any questions, please contact Nikki Ranieri at 215-531-5288.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.