FLSA Status: Non-Exempt
Position Summary
The Maintenance Compliance Specialist - leads the tracking, coordination, and closure of Maintenance related CAPAs, change controls, investigations, and deviations. Assists in the attendance of compliance related meetings, initiation of communications, and timely initiation of necessary technical documentation as situations occur or dictate.
Essential Duties & Responsibilities
Responsible for participating in the following activities within the Maintenance Support Services Function:
- Under the direction of the Technical Services Supervisor, coordinate preventive maintenance instruction reviews with all resource groups periodically.
- Function as the collection point and single point of contact for deviation information and coordinate the proper escalation of information to determine deviation requirement decisions. Attend the daily Triage meeting for Maintenance related information requests and/or to present new deviations.
- Schedule meetings and work with personnel to gather required information and lead deviation investigations, CAPA corrections, and change controls.
- Provides and maintains metrics around equipment compliance workstream closure, including deviation, CAPA and change control status.
- Functions as the organizational Oracle eAMS Bill of Materials (BOM) Editor for changes to equipment BOM’s.
- Maintain an intimate knowledge of all PM, DM, CM, and other maintenance related procedures for rapid assessment of compliance decisions.
- Adhere to cGMP and cGDP guidelines, recommend updates to SOP's and plant policies/rules to maintain compliance where appropriate.
- Perform other related duties as assigned or required.
Knowledge, Skills & Qualifications
- Excellent oral and written communication skills, interpersonal and organizational skills
- Practical understanding of basic equipment operational principals used in an industrial manufacturing environment.
- Proficient with Microsoft Office applications and preferably Oracle applications such as Agile and eAMS
- Good self-discipline and attention to detail
- Must have flexible work hours - willing to work outside normally scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
- Must have the experience and/or ability to work in cleanroom environments and have the physical abilities to pass and maintain gowning certifications
- Must have good planning skills and must be willing to interface with and support team members in many different roles and functions throughout the manufacturing facility.
- Must have advanced skills in Excel
- Must pass GMP and area certifications and trainings.
- Part 11 cGMP experience a plus
- Must be able to qualify and maintain cleanroom gowning qualification
Education And Experience
- Associates degree preferred, OR
- High school diploma or equivalent and:
- Minimum three years’ experience with maintenance documentation change or revision experience
- Two (2) years’ experience preferably in biopharma manufacturing (GMP) or Quality Assurance
- Associate degree and one (1) year of manufacturing experience
Minimum Qualifications
- Must be at least 18 years of age
Travel Requirements: (only select one of the below options)
- Typically requires travel less than 5% of the time
Physical Requirements And Work Environment
- Typical office environment with occasional exposure to manufacturing and warehouse operations as needed for gathering data. Process an extensive amount of paperwork which requires attention to detail and high level of accuracy.
- Must be able to lift to 25 lbs. unassisted. Must be able to sit and stand as required for extended periods of time.
ICU Medical is an Affirmative Action and Equal Opportunity Employer. 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.
Manufacturing
Primary Location
US-TX-Austin
Schedule
Full-time
Shift
Day Job