QC Analyst I - Sample Handler

Bora Biologics USA•Rockville, MD

30d•Onsite

About The Position

This position is responsible for sampling and verification of incoming raw materials to support Bora Biologics CDMO manufacturing and for preparation for shipment to contract testing sites of raw material samples. This position may also be responsible for the sampling and testing of other samples, i.e. drug substance and stability samples.

Requirements

High School Diploma and minimum of two years directly related experience; or Associate’s Degree and minimum of one year directly related experience; or Bachelor’s Degree in a scientific discipline
Experience in one or more of the following areas required: Aseptic technique, cell culture, ISO 5 sampling, ISO 8 sampling, GMP clean experience, Quality Control, or GMP testing.
Working knowledge of good manufacturing practices
Needs to be able to follow directions that are outlined in SOPs and other quality guidelines
Ability to organize daily activities to meet internal customer needs in a fast-paced environment
Be able to work in a team environment in a cooperative and respectful manner
Ability to understand when he/she should seek advice and guidance
Data entry skills
Ability to stand for periods of time when performing tasks on the floor
Ability to work a varied schedule including off shift and weekends
Ability to lift up to 50 pounds

Responsibilities

Performs inspection, sampling and verification of incoming raw materials according to internal specifications, procedures (SOPs), drawings and other applicable controlled documents, per schedule and within established turn-around times.
Collaborates with Materials Management to prepare shipments of raw material samples for testing performed by contract laboratories.
Follows established procedures and performs tasks in accordance with cGMP requirements.
Assists in the development and revision of raw material specifications and testing plans.
Performs physical inspections of stored materials.
Sets down and pulls samples per the stability program.
Records data in LIMS and SAP, ensuring completeness and accuracy per cGMP.
Compiles and reviews data per cGMP.
Ensures data storage and archiving are performed per established procedures.
Ensures that instruments and equipment used in inspection, sampling and testing are kept in a qualified and calibrated state and raises any concerns about equipment to supervisor for resolution.
Maintains the sampling room at constant state of compliance and inspection readiness at all times and ensures that sampling room inventory is stocked with required cleaning solutions, sample containers, labels, etc., and coordinates with appropriate departments when there are issues/concerns.
Reports discrepancies and nonconforming materials to management and supports subsequent investigations and other Quality event records (e.g., Deviations and CAPAs).
Prepares general lab solutions and buffers as needed and monitors expirations of these solutions and buffers.
Performs other duties as assigned.