- Administers the local change control system, records management system, and/or documentation system.
- Ensures Corporate or other site changes relating to Austin processes are reviewed for impact and that Austin commitments are appropriately tracked to completion
- Ensures consistency and compliance of changes with local, corporate and global regulatory requirements (CFR, Health Canada, PIC/s, etc.).
- Evaluate process/procedure changes as necessary. Drive continuous improvement of departmental processes.
- The Plant QA Specialist may be responsible for reviewing and approving Validation documents.
- The Plant QA Specialist may be responsible for facilitating the Change Control Review Board (CCRB) on a specified frequency to discuss and make decisions on change control content, deliverables and any issues that arise.
- The Plant QA Specialist may be responsible for review and approval of facilities, utilities and equipment related SOPs.
- The Change Control Plant QA Specialist may be responsible for daily technical support for change control and document control activities of the Documentation Technicians.
- Come to agreement by managing communications through discussions and compromise.
- Investigate exceptions related to the documentation center or various change control processes to determine root cause and appropriate corrective action(s).
- Write or assist with the writing of Standard Operating Procedures.
- Perform other related duties as assigned or required.
- High level of attention to detail and the ability to prioritize and manage heavy workloads in a dynamic environment.
- Must have thorough knowledge and understanding of cGMPs, FDA and/or pharmaceutical industry guidelines.
- Must have good organizational, presentation, project management, and meeting facilitation skills.
- Must be at least 18 years of age
- Bachelor's Degree is required: Science or Engineering preferred
- 3-5 years of Quality experience in a regulated environment (FDA regulated environment preferred).
- Office environment. Occasional lifting up to 25 lbs. Typically requires travel less than 5% of the time.
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Plant QA Specialist - Austin, United States - ICU Medical Inc.
Description
Plant QA SpecialistPosition is 100% onsite at the Austin TX ICU Medical Plant.
FLSA Status:
Exempt
Position Summary:
Duties may include oversight of various aspects of change control and documentation, including but not limited to change control administration, records management, document control, local change control, and corporate change control.
As a member of the Quality unit this individual is accountable for ensuring that changes made to processes, products or systems have been properly reviewed and approved to maintain proper cGMP control of validated systems.
The Change Control Plant QA Specialist may also be responsible for the review and approval of SOPs and documents related to site GMP facilities, equipment and utilities as well as Validation documents.
The Change Control Plant QA Specialist may also be responsible for daily technical support for change control and document control activities of the Documentation Technicians.
Essential Duties & Responsibilities:
Knowledge, Skills & Qualifications:
Education and Experience:
Physical Requirements and Work Environment:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
