Serán BioScience · 1 month ago
Quality Assurance Associate II/III
Bend, OR
Full-time
Onsite
Mid, Senior Level
3+ years expSerán BioScience is searching for an experienced Quality Assurance Associate to aid in regulatory compliance for the manufacturing of oral solid dosage drug products. The role involves supporting the Quality Assurance department by ensuring GMP regulations are followed and includes responsibilities such as reviewing production records and conducting audits.
Biotechnology
No H1B
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
Qualification
Required
Knowledge of GMP and FDA regulations for clinical trial materials
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
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
Preferred
Commercial knowledge is desirable but not required
Oral Solid Dosage preferred
Benefits
Employees are awarded generous PTO accrual
Low-cost health benefits
5% 401(k) contribution that does not require an employee match or vesting
Serán employees accrue over four weeks of paid time off annually
Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period
Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions
Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage
An Employee Assistance Program provides support for all things related to our employees’ wellbeing
Access to pet insurance
Company
Serán BioScience
At Serán, Our mission is to provide optimized drug development and manufacturing services for our clients, from discovery to the clinic.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Dan Smithey, PhD
President, CEO and Founder
Company data provided by crunchbase