Quality Control Analyst II

Proclinical; Town of Mansfield (NY); Vor Ort; USD 41.000 - 62.000; Teilzeit

Zusammenfassung

Proclinical is seeking a Quality Control Analyst II on a contract basis to join our client in Mansfield, Texas. The role involves routine and non-routine testing, data analysis, and collaboration with cross-functional teams to ensure product quality.

The position requires a degree in a related field, regulated-lab experience, and proficiency with LIMS and common office software. Onsite responsibilities include material testing, environmental monitoring, and participation in audits and training.

Qualifikationen

• Candidate holds a degree in chemistry, biology, biochemistry, or a related field.
• Regulated laboratory experience is required, preferably in QC within pharma/biotech.
• Data analysis and strong attention to detail are essential.
• Good communication and teamwork in a collaborative environment.

Aufgaben

• Perform routine and complex analytical assays for raw materials, in-process samples, and product testing.
• Maintain training records and adhere to testing schedules.
• Assist in maintaining lab equipment, inventory, and reagents.
• Submit and review data for accuracy and accessibility.
• Update SOPs and test methods to support continuous improvement.
• Ensure compliance with GMP, GLP, and ICH guidelines.
• Collaborate with Manufacturing, Materials Management and QA teams.
• Support audits and inspection readiness.

Kenntnisse

Data analysis

Attention to detail

Communication and teamwork

Regulatory compliance awareness

Ausbildung

Degree in chemistry, biology, biochemistry, or related field

Associate's Degree or Biotech Certificate

Tools

LIMS

Excel

Word

PowerPoint

Jobbeschreibung

Quality Control Analyst II - Contract - Mansfield, Texas

Are you passionate about quality and precision? Join our client in this analyst role and help ensure top-tier standards every day.

Proclinical is seeking an Analyst II for Quality Control Operations to support laboratory activities from development through commercialization.

Primary Responsibilities

This role involves performing routine and non-routine testing, contributing to method transfers and validations, and ensuring compliance with regulatory standards. The position is based onsite in Norton, MA, with occasional responsibilities at a secondary location in Cambridge, MA.

Skills & Requirements

• Degree in chemistry, biology, biochemistry, or a related scientific field (Associate's Degree or Biotech Certificate considered).
• Experience in a regulated laboratory setting, preferably in Quality Control within the pharmaceutical or biotech industry.
• Proficiency in data analysis is preferred.
• Strong attention to detail and ability to adapt to shifting priorities.
• Effective communication and teamwork skills in a collaborative environment.
• Familiarity with LIMS, Excel, Word, and PowerPoint is advantageous.

The Quality Control Analyst's responsibilities will be:

• Conduct routine and complex analytical assays to support raw materials, in-process samples, product release, and stability studies.
• Maintain training records, adhere to testing schedules, and ensure timely completion of assignments.
• Assist in maintaining laboratory equipment, inventory, and preparation of reagents and samples.
• Submit data promptly and review data to ensure accuracy and availability.
• Perform operational tasks such as raw material sampling, environmental monitoring, and product testing.
• Update controlled documents, including SOPs, work instructions, and test methods, to ensure continuous improvement.
• Adhere to internal policies and regulatory standards (e.g., GMP, GLP, ICH guidelines).
• Collaborate with cross-functional teams to support seamless quality control operations.
• Participate in ongoing training to enhance expertise in QC techniques and regulatory compliance.
• Support inspection readiness activities and assist during audits and inspections.
• Contribute to continuous improvement initiatives to enhance laboratory efficiency.
• Work closely with other departments, such as Manufacturing, Materials Management, and Quality Assurance, to align with business goals.

Compensation

• $30 to $45 per hour.

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