About the job
POSITION SUMMARY: Reporting directly to the Manager, Quality Assurance, the QA Compliance & Administrative Specialist coordinates overall compliance of document and investigative quality systems. The QA Compliance & Administrative Specialist collaborates with Production to ensure effective root-cause analysis investigations are performed identifying appropriate corrective/preventative measures. In addition, the QA Compliance & Administrative Specialist coordinates collection of quality metric trend data, serves as document control room administrator, facilitates the document change control process, serves as Site Administrator of the electronic quality management system. This role includes the support of all regulatory and customer audits and the performance or facilitation all supplier/service provider and internal audits as Lead Auditor, when appropriate. The QA Compliance & Administrative Specialist always maintains positive and cooperative communications with all levels of associates, customers, vendors and other third parties.
Set yourself apart
PRIMARY DUTIES AND RESPONSIBILITIES:
- Facilitates compliance with all quality system processes to ensure on-time resolution and
- Serves as Site Administrator of MasterControl, an electronic quality management This includes, but is not limited to the following:
- User Management (creating, modifying, and disabling users)
- Document Management (ensuring document creation/revision flows smoothly, formatting is followed, correct approvers are assigned to every packet, assigning effective dates, ensuring all metadata is filled out correctly, providing change control approvals, when applicable, etc.)
- Training Management (ensuring courses are properly set up for all training including creating/assigning competency exams, assigning courses to the correct job code(s), assigning users to the correct job code(s), etc.)
- Manages document control area, offsite storage inventory, and electronic document copies on server per the Document and Record Retention procedure.
- Develops and revises standard operating procedures (SOPs), when needed.
- Performs root cause analysis investigation of customer and supplier complaints.
- Performs root cause analysis investigation of internal product quality issues, when needed.
- Documents quality assessments and investigational findings related to complaint investigations, drafts customer response letters for
- Performs CAPA investigations, implementations, and/or effectiveness
- Generates and executes validation and protocol documentation as need
- Performs new hire quality training and other quality training sessions, as
- Distributes associate training status reports and other open quality system
- Supports all regulatory agency and customer audits.
- Performs or facilitates all supplier, service provider and internal audits as Lead Auditor, when appropriate.
What’s on offer?
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- EXPERIENCE AND EDUCATIONAL REQUIREMENTS: An associate or bachelor’s degree in a science related field or industry-equivalent experience required; minimum of five (5) years of progressive responsibilities in quality assurance/control experience required; or an equivalent combination of education and experience. Experience in the pharmaceutical industry preferred.
- LANGUAGE ABILITY: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals that are grammatically
- MATH ABILITY: Ability to work with mathematical concepts such as probability and statistical inference and apply the concepts to practical
- REASONING ABILITY: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete
- COMPUTER SKILLS: To perform this job successfully, an individual should have advanced knowledge in the Microsoft Office suite of applications including Word, Excel, PowerPoint and Outlook and with Internet Explorer. Experience with electronic document control systems and electronic quality management systems