Senior Site Specialist

Job Title: Sr. Site Specialist

Location: Indianapolis IN 46221 US

Duration: 3 Months

Shift: Minday to Friday (7:30AM to 4:00PM)

How do we make an impact:

• The position is focused primarily on scientific support services within Unity Lab Services core offerings of order entry order management operating customer procurement systems stockroom services material handling shipping/receiving chemical tracking and glass wash operations.
• May also include media preparation and cell culture support operations.

How will you get here:

• Education: High School Diploma college degree preferred
• Experience: 23 years of equivalent experience preferably within a laboratory setting or services. Demonstrated customer service verbal written and presentation skills.

Knowledge Skills Abilities:

• Demonstrates ability to read write and speak English fluently using strong communication skills and desire to deliver excellent customer service including maintaining a professional appearance in all interactions and upholding.
• Knowledgably operates handheld scanners and performs data entry function.
• Demonstrates computer proficiency and possess intermediate skills in Microsoft Office suite of software. Uses organizational skills to multitask and meet due dates as needed.
• Works primarily at customer sites which may require working independently. Work areas may include spaces where chemicalbased allergens may be in use (such as penicillin tetracycline etc.)
• Depending on the area of building personal protective equipment may be worn to include lab coats coveralls hood facemask hairnets safety gloves and safety glasses steel toe shoes bump hats and/or safety glasses.
• Requires the ability to lift push and pull 3040 pounds consistently; may be required to lift fifty pounds including operation and use of pushcarts pallet jacks forklifts etc.
• The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not a comprehensive list of all the duties and responsibilities associated with it.

Summary:

• The Senior QA Technician position ensures the equipment used RDS meets or exceeds the internal/external customer expectations and compliance with standards. Directly supports all departments onboard and maintains all equipment with quality oversight as per company policies and procedures.

Responsibilities:

• Maintain documents including organizations (GMP) equipment files and project associated files (e.g. batch records testing records validation records and other documents as applicable)
• Manage appropriate labeling and signage of equipment service status.
• Manage and maintain filing system of Equipment Master Log including issuance of equipment numbers calibration and preventative maintenance schedules.
• Support internal/external audits as needed.
• Meet regulatory requirements internal KPIs and provide department metrics as needed to management.
• Manage and audit all new equipment as needed.
• Assist with creation and/or updating of Equipment Operating Procedures
• Be able to lift to 50lbs when required.
• Other duties as assigned as an emerging growth company it may be required from time to time to assist in other areas other than the area of specialty

Knowledge And Skill:

• Working knowledge of MS Office. MS Word skills required: templates styles headers working with cross referencing figures tables and sections.
• Working knowledge of QCBD and Master Control
• Working knowledge of FDA QSR GMP and ISO 13485 is a plus.
• Ability to work effectively independently as well as part of a cross functional team.
• Ability to relate and collaborate well with people.
• Excellent organizational skills
• Excellent verbal/written communication skills
• Diligence.
• Ability to multitask and work well under pressure

Education/Experience Required:

• High School Diploma plus a minimum of 1 years detailed oriented work experience in a GMP regulated environment experience with maintaining equipment records in an eQMS or CMMS is preferred.

Physical Demands:

• Ability to execute under pressure with short turnaround times.
• Ability to work overtime on occasion to support business needs may include weekend or holidays.
• Ability to speak write and use all office equipment including scanner and printer phone computer etc.
• Regular use of fine motor skills
• Ability to lift and/or move objects that weigh more than thirty pounds.
• Regularly required to stand walk stoop kneel crouch or crawl
• Specific vision abilities required for this job include close vision distance vision color vision
• peripheral vision depth perception and ability to adjust and focus.