Biotechnology and Pharmaceutical, Manufacturing and Production, Other / General, Quality Control
QC Technician 2
This position is responsible for acquiring the skills to inspect and accept/reject incoming raw packaging materials and components, supervise 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, get along with all levels of employees and customers, and assists QA personnel, as vital. This position uses database applications and standard precautionary procedures, be self-directed, communicate optimally, and use good judgment when making decisions. Internal or external client interaction occurs under the mentorship of experienced professional or technical staff.
Essential Duties and Responsibilities:
Must be able to optimally perform 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 accurate, error-free, and entered into appropriate operating systems daily.
May be required to travel to other facilities to meet business needs.
Other duties may be assigned to meet business needs.
QC Technician 2 must apply skills to perform the following duties:
Work with operations staff to identify and resolve all issues that may result in a non-conformance or atypical event.
Assist in training technicians in accurate procedural and protocol adherence and data collection.
Ensure facility compliance to cGMP requirements and FBS quality systems and SOPs.
Collect, trend and analyze Quality Control Data as well as maintain the QC Work Logs
Basic Minimum Qualifications: The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job optimally, an individual must be able to complete each crucial 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 ability to work independently and as part of a team.
Requires proficiency of Windows and Microsoft office applications and the ability to learn new computer systems quickly.
Prefer proficiency in application of 21 CFR Parts 11, 210, 211, and 820, as well as ICH 7 and 8.
Requires High School Diploma; Life Science degree is highly desirable.
Requires a minimum 2 years relevant QC experience or combination of education and experience.
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:
GMP Training preferred
8AM to 5PM core hours with additional hours as the need arises. 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.
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.