QC Analyst I - Sample Handler

Bora Pharmaceuticals; Rockville (MD); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Health coverage

401k matching

Paid time off

Professional development

Wellness programs

Employee Assistance Program

Job summary

Bora Pharmaceuticals in Rockville, MD is seeking a Materials Verification Technician to inspect, sample and verify incoming raw materials for cGMP manufacturing. You will coordinate with Materials Management to ship samples for testing at contract labs and assist in maintaining documentation and data in SAP/LIMS.

Primary duties include following SOPs, supporting stability sampling, and ensuring equipment and room readiness.

Qualifications

• High School Diploma with 2+ years directly related experience.
• Associate's Degree with 1+ year directly related experience.
• Bachelor's Degree in a scientific discipline.

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.

Skills

Aseptic technique

Cell culture

GMP knowledge

Quality Control

GMP testing

Education

High School Diploma

Associate's Degree

Bachelor's Degree in a scientific discipline

Job description

About Bora:

Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from FirstinHuman through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purposebuilt for commercialization. Our inspectionproven, bicoastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.

Job 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.

Essential Functions:

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Responsibilities and Job Duties

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• 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.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Experience & Skills:

Education, Experience, & Credentials

• 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

Supervisory Responsibilities

* None

Salary Range:

$60,000-$75,000

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.