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Serán BioScience

Posted 4 months ago

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Quality Assurance Associate II/III (Swing Shift)

Bend, OregonOn-siteFull-time

AI Summary

Quality Assurance Associate II/III ensuring GMP compliance for oral solid dosage manufacturing, reviewing and approving production records, conducting risk analyses and investigations, and supporting audits and inspections.

About this role

Serán BioScience is searching for an experienced Quality Assurance Associate to aid in regulatory compliance for the manufacturing of oral solid dosage drug products. The primary responsibilities of this role will be to support the daily activities of Serán’s Quality Assurance department by ensuring GMP regulations and internal SOPs are followed throughout the clinical manufacturing process. Essential task include reviewing and approving production records, analytical data, and internal QA documentation. Additional responsibilities include conducting risk analyses and investigations and participating in audits and inspections. Quality experience in a GMP Pharmaceutical Manufacturing setting is a requirement for this position with the ability for the title and compensation to commensurate with experience.
This role will support the alternative manufacturing schedule from Monday - Thursday, beginning at 2:00 pm and ending at 1:00 am. Experience specific to Serán's manufacturing capabilities and confidence to make independent decisions in alignment with Company policies and risk mitigation philosophies will be critical to this role.

Duties and Responsibilities

  • Documents authorships, reviews, and approves of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications
  • Applies working knowledge of best practices in GMP and understands 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
  • Performs quality reviews with minimal oversight
  • Communicates quality-related information to internal teams with minimal guidance
  • Responsibilities may increase in scope to align with company initiatives
  • Performs all other related duties as assigned

    • Required Skills and Abilities

  • Knowledge of GMP and FDA regulations for clinical trial materials; commercial knowledge is desirable but not required
  • Confident understanding of change control procedures, CAPA program, investigation and root cause analysis, and good documentation practices
  • Excellent organizational skills and attention to detail
  • Excellent time management skills with a proven ability to meet deadlines
  • Strong analytical and problem-solving skills
  • Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the company
  • Demonstrates the ability to collaborate and work in cross-functional teams
  • Accepts feedback from a variety of sources and constructively manages conflict
  • Ability to prioritize tasks and to delegate them when appropriate
  • Excellent verbal and written communication skills
  • Ability to function well in a high-paced and at times stressful environment
  • Proficient with Microsoft Office Suite or related software
  • Ability to solve complex problems, take a new perspective on existing solutions, and exercise sound judgment based on the analysis of multiple sources of information to make independent decisions

    • Education and Experience

  • 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

    • Physical Requirements

  • Prolonged periods of sitting or standing at a desk and working on a computer
  • Must be able to lift up to 15 pounds at times
  • Ability to wear required personal protective equipment (PPE), including safety glasses, hearing protection, hard hat, and safety shoes
  • Adheres to consistent and predictable in-person attendance

    • Skills

    Batch RecordsCAPACertificate Of AnalysisChange ControlEquipment QualificationFDA RegulationsGMPMethod ValidationQuality AuditsRoot-cause Analysis

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