GMP QA Associate II (2nd Shift) — Compliance & Audits

Seranbio; Bend (OR); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health insurance

Life and disability coverage

Employee assistance program

Pet insurance

Job summary

Serán BioScience is seeking an experienced Quality Assurance Associate to support GMP compliance in the manufacturing of oral solid dosage drug products. The role emphasizes reviewing production records, analytical data, and QA documentation, with audits and inspections as core duties.

The position requires GMP/QA expertise and the ability to work in a regulated environment, collaborating across teams. Compensation will reflect experience and responsibilities, with potential for title

Qualifications

• Bachelor’s degree, preferably in a scientific discipline.
• 3 years of GMP experience within a QC or QA role to meet the minimum qualifications for an Associate II.
• 6 years of GMP experience within a QC or QA role to meet the minimum qualifications for an Associate III.
• Pharmaceutical Manufacturing experience required, Oral Solid Dosage preferred.

Responsibilities

• Documents authorship, reviews, and approves SOPs, batch production and QC records, certificates of analysis, method validations, and equipment qualifications.
• Applies working knowledge of GMP best practices and how Quality integrates with other business areas.
• Initiates and oversees investigations.
• Manages corrective and preventive actions (CAPA).
• Supports internal audits, client audits and regulatory inspections, with the potential to host.
• Manages controlled document issuance and archival.

Skills

GMP knowledge

CAPA management

Root cause analysis

Documentation practices

Cross-functional teamwork

Time management

Attention to detail

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

Serán BioScience is seeking an experienced Quality Assurance Associate to support GMP compliance in the manufacturing of oral solid dosage drug products. The role emphasizes reviewing production records, analytical data, and QA documentation, with audits and inspections as core duties.

The position requires GMP/QA expertise and the ability to work in a regulated environment, collaborating across teams. Compensation will reflect experience and responsibilities, with potential for title