The Quality Control (QC) Associate I is responsible for performing analytical testing and laboratory activities that support stability, qualification/validation, and release testing of biologics in a cGMP-regulated environment. This role supports routine QC operations through the execution of analytical methods, data review, equipment maintenance, QC inventory management, and continuous improvement initiatives while ensuring compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulatory requirements.

The successful candidate will demonstrate technical expertise, attention to detail, data integrity awareness, and a commitment to maintaining inspection readiness while supporting internal and client-driven programs.

Responsibilities

Essential Duties and Responsibilities

Analytical Testing and Laboratory Operations

Perform routine and non-routine analytical testing of in-process, release, stability, raw material, and investigational samples using approved methods and procedures.

Execute a variety of analytical techniques commonly used for biologics and large-molecule products, including but not limited to:

• CE-SDS
• Endotoxin
• Raw Material Testing
• ELISA
• UV-Vis Spectroscopy
• Compendial testing
• Other biochemical and physicochemical methods as applicable.
• Ensure all testing activities are completed accurately, efficiently, and within established timelines.
• Maintain laboratory notebooks, worksheets, logbooks, and electronic records in accordance with GDP and ALCOA+ data integrity principles.
• Ensure all activities comply with GMP, ALCOA+ principles, and data integrity regulations (FDA, EMA, ICH guidelines).

Other Lab Responsibilities/Skills

• Participate in lifecycle management activities including GMP document management, sample storage/inventory management, and materials ordering.
• Perform first-person review of analytical data to ensure completeness, accuracy, and compliance with applicable procedures and regulatory requirements.
• Ensure documentation is complete, contemporaneous, attributable, and inspection ready.
• Maintain laboratory equipment records and ensure equipment remains in a qualified state.
• Support laboratory readiness for internal audits, client audits, regulatory inspections, and quality assessments.
• Participate in process improvement initiatives to enhance laboratory efficiency, compliance, and data integrity.
• Collaborate effectively with cross-functional teams including QA, Manufacturing, and Materials Management.
• Support implementation of new technologies, systems, and laboratory processes readiness activities.

Qualifications

• Bachelor’s degree in biology, Biochemistry, Chemistry, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline required.
• 0–2 years of laboratory experience in biotechnology, pharmaceutical, or related industries.

Physical Requirements

Stand/walk during entire length of shift.
Use of arms, hands and fingers to handle, feel or reach.
Ability to climb, balance, stoop, kneel, crouch, or crawl.
Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus.
Environment: GMP-regulated Quality Control laboratory.
Chemical Exposure: Frequent handling of organic solvents, acids, buffers, and standards (e.g., methanol, acetone, IPA, acetonitrile).
Hazard Exposure: Potential contact with materials classified as corrosive, flammable, toxic, carcinogenic, or reproductive hazards (e.g., boric acid, β-mercaptoethanol, sulfuric acid, silver nitrate).
Safety Protocols: Strict adherence to the Chemical Hygiene Plan, SOPs, and Safety Data Sheet (SDS) instructions is required.
PPE Requirements: Mandatory use of lab coats, nitrile gloves, and safety glasses. Tasks may require face shields, splash goggles, or respiratory protection.
Daily Activities: Frequent pipetting, weighing, reagent preparation, and instrument operation. Handling of hazardous materials occurs inside laboratory hoods.
Physical Effort: Regular sitting, standing, walking, bending, reaching, and repetitive hand movements.
Lifting: Ability to occasionally lift and transport laboratory supplies up to 25 pounds.