QC Analyst

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Title: QC Analyst II

Hiring Organization: Connexion Systems & Engineering

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Duration: Temp to Perm

Pay rate: $40-45/ hour

Job Location: Watertown, MA

Job# 17651

Overview:

An established pharmaceutical organization is seeking a Quality Control Analyst with a strong background in GMP-regulated laboratory environments. The ideal candidate will have at least 3 years of hands-on quality control experience in the pharmaceutical industry, with a solid understanding of analytical chemistry and lab-based testing methods. Candidates must hold a bachelorâ s degree in chemistry, biology, or a related discipline.

Key Responsibilities:

Conduct analytical testing on pharmaceutical raw materials and finished drug products (release and stability).

Evaluate and reduce testing data in accordance with GMP standards and regulatory guidelines (21 CFR Parts 11, 210/211, USP/EP, ICH).

Preferred Skills and Qualifications:

Minimum 3 years of QC lab experience in a GMP pharmaceutical environment (non-food, non-biologics).

Proficiency in analytical techniques, including HPLC. Familiarity with Empower software is strongly preferred.

Knowledge of laboratory equipment (balances, pipettes, pH meters, etc.).

Strong documentation, organizational, and communication skills.

Ability to work independently and collaboratively, depending on the shift.

Flexible to work weekend shifts where a smaller team environment may apply.

Must be comfortable wearing basic PPE (lab coat, gloves, safety glasses; respirators available when needed).

Bachelor's degree in Chemistry, Biology, or related scientific field (mandatory).

Perform technical data reviews, assist in method validation and transfers, and author SOPs and related QC documentation.

Support inspection and testing of incoming raw materials, reagent preparation, and lab housekeeping.

Ensure compliance with internal procedures and external regulatory standards through all QC processes.

Assist with deviation investigations, OOS/OOT reporting, and provide analytical support for development protocols.

Participate in internal/external audits and inspections, serving as a subject matter expert when necessary.

Support sample management and data trending initiatives.

Assist with training programs for new QC analysts.

Follow safe laboratory practices and proper handling of hazardous materials.