JOB DESCRIPTION

Business Title:

Quality Control Technician 1

Division/Business:

CTD BioServices

Internal Title:

QC Technician 1

Position Location:

Rockville, MD

Career Track/Band:

Associate/Band 01

FLSA Status:

Non-Exempt

Job Family:

Operations/Quality Control

Hours/week:

40 hours/week

Reports To:

Quality Manager/Supervisor

Schedule:

Mon-Fri or Tues-Sat

Relocation:

No

Undated:

January 2016

At Fisher BioServices, we specialize in the management of critical biological materials in support for the advancement of cell therapy, high value biologics, and population-based public health research. We provide customized end-to-end chain of custody solutions for our large pharmaceutical clients and partners in academia and government, ensuring the integrity and efficacy of their valued material from the manufacturer to the bedside. Fisher BioServices is a brand of Thermo Fisher Scientific, the world leader in serving science, and member of the Pharma Services Division. To learn more please visit www.thermofisher.com.

Position Summary: This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. This position is entry level and is responsible for acquiring the skills to inspect and accept or reject incoming raw packaging materials and components, monitor operational activities for compliance with current Good Manufacturing Practices (cGMP) and SOPs, work on semi-routine tasks where ability to recognize deviation from standard practice is required. This position also conducts QC activities within a specified timeline to meet customer requirements, interact with all levels of employees and customers, and assists QA personnel, as necessary. This position uses database applications and standard precautionary procedures to work independently, be self-directed, communicate effectively, and use good judgment when making decisions. Internal or external client interaction occurs under the guidance of experienced professional or technical staff.

Essential Duties and Responsibilities: QC Technician 1 duties:

• Ensures that operations personnel adhere to standard operating procedures and follow Batch Record

instructions

• Approves and controls labels.

• Reviews documents completed by operations personnel.

• Resolves production/QC and documentation discrepancies.
• Responds to inquiries on quality control activities and schedules in general.
• Collects and trends Quality Control Data and maintains the QC Shipping & Receiving Logs
• Ensures all job related paperwork is correct, error-free, and entered into appropriate operating systems daily.
• May be required to travel to other facilities to rneet business needs.
• Other duties may be assigned to meet business needs.

Basic Minimum Qualifications: The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job successfully, an individual must be able to complete each essential duty.

•Requires ability to communicate effectively verbally and in written form.

• Requires ability to be pay attention to detail/follow up.
• Requires excellent interpersonal, problem solving and planning/organization skills.
• Requires knowledge of Windows and Microsoft office applications.

•Requires ability to learn new computer systems quickly.

• Requires ability to work independently and as part of a team.
• Prefer proficiency in application of 21 CFR Parts 11, 210, 211, and 820, as well as ICH 7 and 8.

Education/ Experience:

• Requires High School Diploma; Life Science degree preferred.

•Prefer 1+ years of work experience with data entry and inspection.

• Prefer prior experience in pharmaceutical production or inspection (cGMPs).

• Prefer proficiency in cGMP requirements as they relate to holding and distributing finished pharmaceuticals and biological specimens.
• Prefer knowledge of Universal Precautions, general laboratory and quality assurance/control.

Certificates and/ or Licenses:

• IATA Dangerous Goods Training for Class 6.2 Shipping .
• Blood Borne Pathogens Training.

Supervisory Responsibility: None.

Work Schedule:

8AM to 5PM core hours with additional hours as required. May be required to work non-traditional work week or work hours.

Work Conditions/Physical Requirements:

• Ability to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature .
• May push/pull 600 lb liquid nitrogen dewars, and work from a platform ladder.
• Must use personal protective equipment and adhere to safety protocols.
• Must be able to lift and carry up to 50 lbs, and push up to 70 lbs.
• Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-196°C) for up to 6 hours per day.
• Must be able to work in walk-in freezers or refrigerators periodically for up to 5 hours per day.
• Must be able to use a computer up to 6 hours per day.