QC Associate I/II - Contract

The Quality Control (QC) Associate I / II is responsible for performing analytical testing and laboratory activities that support stability, qualification/validation, and supporting release testing of biologics in a cGMP-regulated environment. This role supports routine QC operations through the execution of analytical methods, data review, laboratory investigations, method transfer activities, equipment maintenance, 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 strong technical expertise, attention to detail, data integrity awareness, and a commitment to maintaining inspection readiness while supporting internal and client-driven programs.

Responsibilities

Analytical Testing and Laboratory Operations

Perform routine and non-routine analytical testing of in-process, release, stability, characterization, reference standard, 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:

• HPLC/UHPLC
• CE-SDS
• cIEF/icIEF
• 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).
• Review and support validation documentation, test scripts, and execution records. LIMS knowledge is a plus.
• Identify and escalate compliance risks during system transition.
• Support analytical method transfer, qualification, verification, and validation activities from Analytical Development or external clients into GMP QC laboratories.

Other Lab Responsibilities/Skills

• Participate in comparability, bridging, and lifecycle management activities for analytical methods and reference standards.
• Perform first-person review of analytical data to ensure completeness, accuracy, and compliance with applicable procedures and regulatory requirements.
• Assist in the preparation and review of: Certificates of Analysis (CoA), Stability Summary Sheets (SSS), Analytical reports, Method qualification and validation reports, technical memoranda and laboratory documentation. Ensure documentation is complete, contemporaneous, attributable, and inspection ready.
• Participate in laboratory investigations involving: OOS, OOT, invalids, and other lab investigations as needed.
• 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, AMD, Manufacturing, MSAT, and Materials Management.
• Support implementation of new technologies, systems, and laboratory processes.

Qualifications

Working Conditions & Physical Demands

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.

We are committed to providing an inclusive and accessible workplace. The essential functions of this role can be performed with or without reasonable accommodation. If you require an accommodation during the application process or to perform the job, please contact Human Resources.