Analytical Quality Assurance Analyst I

Nesco Resource; Fall River (MA); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking an Analytical Quality Assurance Analyst I to ensure product quality and compliance with industry standards. The successful candidate will have a minimum of 3 years' experience in a GMP environment and will undertake various testing and documentation tasks critical to the manufacturing process. With a comprehensive benefits package, this role offers a dynamic work environment aimed at achieving high-quality outcomes.

Benefits

Comprehensive benefits package

Medical, Vision, and Dental coverage

401K

Employee Assistance Program

Qualifications

• 3 years' experience in quality assurance in GMP environments.
• Knowledge of cGMP and strong attention to detail is crucial.
• Advanced education in related fields is preferred.

Responsibilities

• Perform in-process testing according to manufacturing records.
• Conduct room and equipment checks before manufacturing stages.
• Inspect products and maintain quality records.

Skills

Attention to Detail

Good Manufacturing Practices (cGMP)

Decision-Making Influence

Education

Vocational training in pharmaceutical manufacturing

Tools

SAP

Microsoft Office

Job description

Analytical Quality Assurance Analyst I

Responsibilities

• Perform in-process testing (e.g. weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
• Conduct room and equipment checks (where applicable) prior to each stage of manufacturing by following detailed written procedures.
• Execute acceptable quality limit (AQL) sampling and inspections as required.
• Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab and following detailed documentation procedures to deliver the results to the QC Lab.
• Maintain records of standard weights and perform daily verification of balances.
• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.
• Monitor facility and product environmental operating conditions.
• Review of engineering records such as temperature and humidity data calibration and PM records, Pest control records and contractor related functions.
• Assess online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.
• Verify functionality of all the equipment and associated controls during the batch run.
• Perform applicable testing and prepare reports for customer complaints.
• Identify and report any non-conformances and/or discrepancies to management if applicable.
• Complete other duties or participate in project work as assigned by management.

Requirements

• 3 years' experience in a quality assurance in a GMP pharmaceutical manufacturing operation and work environment.
• Advanced vocational training or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university.is preferred.
• Experience in MDI or parentals preferred.
• Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications.
• Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
• Must have current Good Manufacturing Practices (cGMP) knowledge.
• Must have strong attention-to-detail.

Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.