SCCA - 2018
US ~ Boothwyn, PA
Senior Calibration and CMMS Administrator
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specializing in delivering innovative solutions that integrate formulation development, real-time GMP manufacturing, and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
GENERAL PURPOSE OF JOB
The position may reside in any one of the functional areas and carry out the responsibility without supervision:
- Scheduling of calibration activities with internal customers and external vendors, as necessary.
- Execution of assigned maintenance activities, which includes calibration activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- To complete equipment instrumentation audits for generation of Instrument Impact Assessments. Audits include proper identification of instrumentation loop components and compiling critical documentation pertaining to each component (e.g. – manuals, specifications, configuration/setup sheets, etc.).
- Performs maintenance, testing, troubleshooting, calibration and repair on a variety of circuits, components, analytical equipment and instrumentation for pharmaceutical laboratory and manufacturing equipment.
- Utilizes several database systems.
- Analyzes results and may develop test specifications and electrical schematics.
- Maintains all logs and required documentation.
- Prepares technical reports with recommendations for solutions to technical problems.
- Reads, writes and follows Standard Operating Procedures (SOP’s).
- Writes IQ/OQ/PQ’s, Out-Of-Tolerances (OOT’s) and Deviations.
- Disassembles and reassembles instruments and equipment, using hand tools, and inspects instruments and equipment for defects.
- Performs validations on environmental chambers.
- Modifies performance and operation of component parts and circuitry to specifications, using test equipment and precision instruments.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirement
- Supervises external contractors in association with assigned maintenance activities.
EDUCATION and/or EXPERIENCE:
- Desired: Bachelor of Science or specialty degree/certification from a vocational institution for metrology.
- Required: 3-5 years performing process instrumentation calibration.
- Desired: 1-3 years of working in a FDA regulated GxP environment, an ISO 9002 environment, or other regulated environment with a defined quality system (e.g. – nuclear).
- Desired: 1-3 years of direct usage of a CMMS.
- Must be fluent in the English language, both written and verbally.
- Must be able to utilize technical documentation (e.g. - manuals, specifications, drawings, etc.) to complete assigned maintenance activities.
- Must be able to assist in root cause analysis of instrumentation/equipment failures.
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
- Required: Proficiency with Microsoft Office products including: Word, Excel, and Outlook.
- Required: Ability to work independently as well as with others in a team environment.
- Desired: ISA Certified Control Systems Technician Certification
- Ability to work independently as well as with others in a team environment
- Frequently required to stand
- Frequently required to walk
- Frequently required to sit
- Frequently required to utilize hand and finger dexterity
- Occasionally required to climb, balance, bend, stoop, kneel or crawl
- Continually required to talk or hear
- Continually required to smell
- Occasionally exposed to wet and/or humid conditions (non-weather)
- Frequently work near moving mechanical parts
- Occasionally work in high, precarious places
- Occasionally work around fumes, airborne particles, or toxic chemicals
- Occasionally exposed to outside weather conditions
- Occasionally exposed to extreme heat or cold (non-weather)
- The employee must occasionally lift and/or move up to 40 pounds
- Specific vision abilities required by this job include: Close vision; Distance vision; Color vision; Peripheral vision; Depth perception and ability to adjust focus.
- Must be able to met OSHA requirements to wear respiratory personal protective equipment (PPE).