QC Raw Materials Associate II (Contract )

BioPharma Consulting JAD Group; Waltham (MA); On-site; USD 100,000 - 125,000; Full time

Job summary

An established industry player in pharmaceutical manufacturing is seeking a QC Raw Materials Associate II to enhance their Quality Control Raw Material Program. This role is pivotal in ensuring the integrity of materials used in GMP manufacturing. You will be responsible for receiving, sampling, inspecting, testing, and releasing raw materials, while maintaining a compliant and organized laboratory environment. This is an excellent opportunity for someone with a technical background and a passion for quality assurance to contribute to innovative projects in a dynamic setting. Join a team dedicated to excellence and make a meaningful impact in the biotech field.

Qualifications

• 1-5 years' experience in GMP pharmaceutical/biotech industry.
• Experience with quality control methodologies and raw material testing.

Responsibilities

• Receive, sample, inspect, test, and release raw materials per SOPs.
• Maintain laboratories in a safe, cGMP compliant state.

Skills

Independent Work

Communication Skills

Organizational Skills

Attention to Detail

Education

Bachelor's in Technical Discipline

Tools

SAP

Veeva

LIMS

FT-IR

Raman

NIR

Dot-blot

ELISA

HPLC

pH

Visual Inspection

Job description

QC Raw Materials Associate II (Contract)

The QC Associate II will support the QC Raw Material Program. You will be primarily responsible to receive, sample, inspect, test, and release materials for use in GMP manufacture.

Responsibilities:

• Receive, sample, inspect, test, and release incoming raw materials, reagents, and components in compliance with SOPs.
• Maintain laboratories in a safe, cGMP compliant and inspection-ready state.
• Maintain inventory of supply and reagents.
• Perform routine maintenance of lab equipment.
• Support onboarding and qualification of materials by assisting in the preparation of documentation to facilitate material release and testing as part of technology transfer.
• Maintain strict adherence to cGMP compliance and all applicable regulations.

Skills:

• Ability to work independently.
• Ability to communicate/collaborate with scientific/technical personnel.
• Excellent organizational skills and attention to detail.

Requirements:

• BS in a technical discipline with at least 1-5 years' experience in GMP pharmaceutical/biotech industry within Quality Control, MSAT, Process Development or related area to Raw Materials technical expertise.
• Experience with raw material testing programs and quality control methodologies (FT-IR, Raman, NIR, Dot-blot, ELISA, HPLC, pH, Visual Inspection, etc.).
• Knowledge of GMPs, SOPs, and Quality System processes.
• Experience with electronic management systems (SAP, Veeva, LIMS) is a plus.
• Experience in cell and gene therapy manufacturing environment is a plus.

Seniority Level: Associate

Employment Type: Contract

Job Function: Quality Assurance

Industries: Pharmaceutical Manufacturing