QC Analyst I - Sample Handler
Bora Pharmaceuticals
Summary
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.
Job description
Responsibilities and Job Duties
- 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.
Minimum Education, Experience & Skills
- 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.
Knowledge, Skills and Abilities
- 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
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
- Ability to follow directions outlined in SOPs and other quality guidelines
- Ability to organize daily activities to meet internal customer needs in a fast-paced environment
- Ability to work in a team environment in a cooperative and respectful manner
- Ability to understand when to 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
Benefits
- Competitive salary
- Performance-based incentives
- Medical, Dental & Vision
- Retirement savings plans
- Employer matching contributions
- Paid time off
- Professional development opportunities
- Employee wellness programs
- Employee Assistance Program
- Mental Health Resources
Company overview
Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) headquartered in Taipei, Taiwan, with a global presence across North America and Asia. Founded in 2007 by Bobby Sheng, the company operates ten state-of-the-art CGMP manufacturing facilities strategically located to serve over 100 markets worldwide. Bora specializes in comprehensive pharmaceutical development and manufacturing solutions for a wide range of dosage forms including oral solid dose, liquids, semi-solids, ophthalmics, biologics, and sterile injectables. The company employs a distinctive dual-engine strategy that combines scalable CDMO services with innovative drug development focused on specialty pharmaceuticals and rare diseases. With a workforce of 1,001-5,000 employees, Bora provides end-to-end services from early phase clinical development through commercial manufacturing, supported by full packaging capabilities. The company is publicly traded on the Taiwan Stock Exchange (TWSE: 6472) and has established itself as a trusted partner for biopharmaceutical companies globally through its commitment to quality, operational excellence, and strategic growth initiatives.