Quality Assurance Associate II/III at Serán BioScience

Bend, Oregon, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

Bachelor’s degree, preferably in a scientific discipline
3 years of GMP experience within a QC or QA role for Associate II (minimum)
6 years of GMP experience within a QC or QA role for Associate III (minimum)
Pharmaceutical Manufacturing experience required; Oral Solid Dosage preferred
Knowledge of GMP and FDA regulations for clinical trial materials (commercial knowledge desirable)
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 ability to meet deadlines
Strong analytical and problem-solving skills
Excellent verbal and written communication skills
Ability to communicate effectively and maintain productive relationships with coworkers, clients, and external contacts
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 delegate when appropriate
Ability to function well in a high-paced and stressful environment
Proficient with Microsoft Office Suite or related software
Ability to solve complex problems, take new perspectives on solutions, and exercise sound judgment based on multiple information sources
Physical ability to sit/stand prolonged periods at a desk/computer, lift up to 15 pounds, and wear required personal protective equipment

Responsibilities

Authors, reviews, and approves SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications
Applies working knowledge of GMP best practices and understands Quality integration with other business areas
Initiates and oversees investigations
Manages corrective and preventive actions (CAPA)
Supports internal audits, client audits, and regulatory inspections (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
Reviewing and approving production records, analytical data, and internal QA documentation
Conducting risk analyses and investigations
Participating in audits and inspections
Ensuring GMP regulations and internal SOPs are followed throughout the clinical manufacturing process

Skills

Key technologies and capabilities for this role

GMPSOPBatch RecordsQC RecordsCAPARisk AnalysisAuditsInspectionsInvestigationsMethod ValidationsEquipment QualificationsRegulatory CompliancePharmaceutical Manufacturing

Questions & Answers

Common questions about this position

What benefits does Serán BioScience offer?

Employees receive generous PTO accrual, low-cost health benefits, and a 5% 401(k) contribution that does not require an employee match or vesting.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What are the key skills required for the Quality Assurance Associate role?

Key skills include knowledge of GMP and FDA regulations, understanding of change control, CAPA, investigations, root cause analysis, good documentation practices, excellent organizational skills, attention to detail, time management, analytical and problem-solving skills, and effective communication in cross-functional teams.

What is the company culture like at Serán BioScience?

The company aims to build a workforce that is collaborative, creative, and kind, with qualified candidates approaching work with integrity and enthusiasm to promote a positive work culture.

What experience is needed to be a strong candidate for this position?

Quality experience in a GMP Pharmaceutical Manufacturing setting is required, with the title and compensation commensurate with experience; strong candidates will have knowledge of GMP/FDA regulations and demonstrate integrity, enthusiasm, collaboration, and the listed skills.

Serán BioScience

Contract development and manufacturing for pharmaceuticals

About Serán BioScience

Serán BioScience specializes in providing drug development and manufacturing services as a Contract Development and Manufacturing Organization (CDMO). They offer a variety of services, including preformulation, formulation development, dosage form development, spray drying, and particle engineering. Their operations adhere to current Good Manufacturing Practice (cGMP) standards, ensuring high quality and safety in their products through rigorous analytical quality control. Serán BioScience serves a wide range of clients, from small biotech startups to large pharmaceutical companies, and is distinguished by its flexibility in tailoring services to meet specific client needs. The company's goal is to enhance the efficiency and effectiveness of drug development processes for their clients.

Bend, OregonHeadquarters

2016Year Founded

$194.5MTotal Funding

GROWTH_EQUITY_VCCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Paid Vacation

401(k) Retirement Plan

Health Insurance

Life Insurance

Disability Insurance

Mental Health Support

Pet Insurance

Risks

Emerging CDMOs in Asia offer lower-cost services, impacting Serán's market share.

Potential delays in new facility construction could affect expansion plans.

Global talent shortage may hinder recruitment for Serán's expansion.

Differentiation

Serán specializes in advanced drug formulation techniques, including spray drying and particle engineering.

The company offers cGMP manufacturing and analytical quality control services.

Serán's flexibility allows tailored services to meet specific client needs.

Upsides

Serán announced a $200 million strategic growth transaction for expansion.

The company plans to build a new commercial-scale manufacturing facility.

Increased demand for personalized medicine aligns with Serán's formulation expertise.

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