Serán BioScience

CDMO offering drug formulation & manufacturing

Quality Assurance Senior Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBend, OR, USANo salary listed

About the Job

Requirements

Knowledge of Good Manufacturing Practices and Food and Drug Administration regulations for drug manufacturing (21 CFR 210–211).
Knowledge of Good Manufacturing Practices, Food and Drug Administration, and European Medicines Agency expectations for clinical trial and commercial materials, manufacturing, and testing.
Excellent verbal and written communication skills.
Excellent time-management skills and a demonstrated ability to meet deadlines.
Excellent organizational skills and attention to detail.
Demonstrated ability to collaborate and work in cross-functional teams.
Scientific curiosity and willingness to learn.
Strong analytical and problem-solving skills.
Ability to prioritize tasks and delegate them when appropriate.
Minimum of a bachelor's degree, preferably in a scientific discipline.
At least 8 years of quality assurance experience, including auditing and supplier quality experience.
Must be authorized to work for an employer in the United States.
Must be able to sit for prolonged periods and work at a computer.
Must be able to lift up to 15 pounds.

Responsibilities

Perform the day-to-day tasks of the Quality Assurance Department supporting a Good Manufacturing Practices facility that manufactures, stores, and tests pharmaceutical products.
Oversee Supplier Quality, auditing, and the Quality Risk Management program.
Manage audits and audit responses, facilitate audit-related continuous improvements, and negotiate and process Quality Agreements.
Perform internal and third-party audits.
Support regulatory inspections and client audits, and manage and improve the audit program.
Provide direction on audit operational activities and develop audit responses, Corrective and Preventive Action plans, and Effectiveness Checks.
Oversee the supplier quality program, including supplier qualification and audits.
Assist in overseeing, facilitating, and implementing continuous improvement of the company's quality systems.
Administer the quality risk management program and conduct risk assessments.
Author, review, and approve Standard Operating Procedures, reports, and quality records.
Manage change management, investigations, and Corrective and Preventive Action.

Desired Qualifications

Working knowledge of Veeva.

Serán is seeking a Quality Assurance Senior Specialist who will be responsible for performing the day-to-day tasks of the QA Department supporting a GMP facility manufacturing, storing, and testing pharmaceutical products. Primary responsibilities include overseeing Supplier Quality, Auditing (supporting regulatory and client audits, conducting internal and vendor audits), and managing the Quality Risk Management program. Tasks include audit management, audit response, facilitating audit related continuous improvements, negotiating/processing Quality Agreements and continuous improvement. Additional responsibilities include Quality Management System, risk analyses, change management and investigations/CAPA.

Duties & Responsibilities

Performs internal and third-party audits.
Supports regulatory inspections and client audits. Manages and improves audit program.
Provides direction on audit operational activities and the development of audit responses, CAPA plans, and Effectiveness Checks.
Oversees company’s supplier quality program including supplier qualification and audit (some travel required)
Assists in the oversight, facilitation, and implementation of continuous improvement of the company’s quality systems
Administers the quality risk management program and conducts risk assessments
Document authorship, review, and approval of SOPs, reports, and quality records.

Required Skills & Abilities

Knowledge of GMP and FDA regulations for drug manufacturing (21CFR 210-211).

Knowledge of GMP, FDA, and EMA expectations for clinical trial and commercial materials, manufacturing, and testing

Excellent verbal and written communication skills

Excellent time management skills with a proven ability to meet deadlines

Excellent organizational skills and attention to detail

Demonstrated ability to collaborate and work in cross-functional teams

Scientific curiosity and willingness to learn

Strong analytical and problem-solving skills

Ability to prioritize tasks and to delegate them when appropriate

Education & Experience

Minimum of a Bachelor's Degree, preferably in a scientific discipline

8+ years previous quality assurance experience including Auditing and Supplier Quality experience

Working knowledge of Veeva preferred

Physical Requirements

Prolonged periods of sitting at a desk and working on a computer

Must be able to lift up to 15 pounds

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Benefits Summary:

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, along with access to pet insurance.

The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701

About the Company

Serán BioScience

CDMO offering drug formulation & manufacturing

Serán Bioscience is a contract development and manufacturing organization that helps pharmaceutical companies develop and manufacture drugs. It offers preformulation, formulation and dosage-form development, spray drying and particle engineering, plus cGMP manufacturing and analytical quality control. It relies on flexible, client-tailored services and a broad technical toolkit to support a range of clients from startups to large pharma. Its goal is to enable efficient, compliant drug development and production with rigorous quality standards.

Company size: 51-200
Company stage: Growth Equity (Venture Capital)
Total funding: $200M
Headquarters: Bend, OR
Founded: 2016

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