Quality Control Analyst

We are hiring Quality Control Analyst.

Please let me know if you are interested or anyone who might be interested.

Client: Major Pharmaceutical Client

Position: Quality Control Analyst

Duration: 12 Months Contract

Location: Lexington, MA 02421

Pay Rate: $40.00-$43.00/ Hr on W2

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Description:

Work Schedule: 100% Onsite

Job Description

Primary duties of this position will focus on daily laboratory operations and execution of testing to support manufacturing operations.

Testing may include, but is not limited to:

• Drug substance and drug product samples
• Manufacturing samples
• Stability samples
• Raw materials
• Various protocol studies using established test methods

The assays performed range from routine analytical testing such as pH and enzyme concentration to more complex assays including:

• SDS Silver Gels
• PCR
• DNA analysis
• Enzyme activity assays

This position is expected to maintain operational and GMP readiness of the QC laboratory areas. In addition, the individual will participate in complex projects, operational excellence initiatives, and quality system activities.

QC Focus Area (Biochemistry)

Experience with the following is preferred:

• A280
• SOLO A280
• Compedia methods:
• pH
• Moisture
• Osmolality (OSMO)
• Appearance
• Subvisible particles
• Enzyme activity assays
• DNA analysis
• PCR
• Free Thiol testing

Responsibilities

Testing Execution (80%)

• Execute routine and non-routine QC testing to support manufacturing operations.
• Perform laboratory testing according to approved methods and procedures.
• Accurately document and report testing results.

QC Operations Support (10%)

• Perform data review and trending.
• Support Operational Excellence (OE) and 5S initiatives.
• Maintain laboratory equipment and reagents.
• Prepare reagents.
• Maintain laboratory housekeeping.
• Provide support to other QC groups as needed.

Compliance & Quality Systems (10%)

• Support compliance activities.
• Assist with SOP revisions.
• Provide input to quality systems.
• Maintain GMP compliance and laboratory documentation.

Education & Experience

Required

• Bachelor's degree in Biology, Biochemistry, Chemistry, Molecular Biology, Biotechnology, or a related scientific discipline.
• 1 years of relevant laboratory experience.

Preferred

• Experience working in a GMP-regulated environment.
• Knowledge of quality systems and laboratory compliance requirements.

Required Skills

• Strong scientific understanding and analytical skills.
• Critical thinking and problem-solving abilities.
• Familiarity with laboratory documentation practices.
• Working knowledge of:
• Microsoft Office
• LIMS
• SAP
• TrackWise
• EDMS
• Understanding of GMP compliance.

Problem Solving & Work Environment

• Solve routine laboratory problems following established procedures and policies.
• Analyze laboratory data using standard practices.
• Work independently on assignments of limited scope and complexity.
• Build effective working relationships with supervisors and team members.
• Collaborate with cross-functional laboratory and manufacturing teams.

Regards

Vishnu Das Natesan

dvishnu@radiants.com