Quality Control Analyst III - Contract - Norton MA
Proclinical is seeking a dedicated Quality Control Analyst III to support the department's commitment to maintaining high standards of quality and compliance from development through commercialization.
Primary Responsibilities:
This role will be involved in routine and non-routine testing, data trending, investigations, and laboratory operations. This position requires flexibility for weekend coverage and is primarily based onsite in Norton, MA.
Skills & Requirements:
- Degree in chemistry, biology, biochemistry, or related scientific field.
- Experience in a GMP Quality Control function within the pharmaceutical/biotech industry.
- Knowledge of method transfer and analytical method implementation.
- Strong technical writing skills, particularly for investigations.
- Proficient in data analysis and interpretation with attention to detail.
- Problem-solving skills and experience in conducting investigations and implementing CAPA.
- Strong organizational skills and ability to manage multiple tasks.
- Excellent communication and teamwork abilities.
- Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.
The Quality Control Analyst's responsibilities will be:
- Conduct routine and non-routine analytical and microbiological assays for raw materials, in-process samples, product release, and stability studies.
- Support weekend laboratory operations to maintain a continuous operational schedule.
- Maintain training records, adhere to testing schedules, and ensure timely completion of assignments.
- Assist in maintaining laboratory equipment and inventory, including reagent and sample preparation.
- Review data promptly and qualify as a data reviewer for efficient data availability.
- Perform operational assignments such as raw material processes and environmental monitoring.
- Contribute to revising and updating controlled documents to ensure compliance with industry standards.
- Adhere to internal and regulatory standards to maintain quality and compliance.
- Participate in continuous improvement efforts to enhance laboratory processes.
- Collaborate with QC and cross-functional teams to support seamless operations.
- Pursue ongoing training to deepen expertise in QC testing techniques and regulatory compliance.
- Assist in preparing technical documentation for regulatory submissions.
- Participate in inspection readiness activities and support audits and inspections.
- Collaborate with other organizational functions to align with business goals.
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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