Quality Assurance Associate II/III -Quality Management System

@ Serán BioScience

Quality Assurance Associate II/III -Quality Management System

Posted 2 months ago

This job is still taking applications, but it's been up a while.

About the job

Serán BioScience specializes in pharmaceutical manufacturing, focusing on quality systems in GMP facilities. The QA Associate supports document review, audits, investigations, and maintains electronic Quality Management System to ensure compliance and quality in pharmaceutical production.

Requirements

Knowledge of GMP and FDA regulations
Excellent communication skills
Strong organizational skills
Experience in pharmaceutical quality
Proven time management ability

Qualifications

Bachelor's Degree in scientific discipline
3+ years manufacturing or QA experience
Knowledge of Veeva or SAP preferred
Ability to lift 15 pounds
Able to wear PPE

Full job description

Serán BioScience is searching for an experienced Quality Assurance Associate to support quality systems programs. As a Quality Assurance Associate, you will be responsible for performing the day-to-day tasks of the QA Department in a GMP facility manufacturing pharmaceutical products. Tasks include supporting quality system programs such as document management, training, and quality event programs. Additional responsibilities include assisting in the maintenance of the electronic Quality Management System, conducting risk analyses and investigations, and participating in audits and inspections. Preference will be given to candidates within the pharmaceutical industry, while those with Quality oversight experience encouraged to apply.

Duties and Responsibilities

Supports the implementation and continuous improvement of the company’s Quality systems
Assists in monitoring of Serán quality systems through trending and metrics analysis
Supports the management of Serán’s quality systems through program oversight and eQMS administrative functions.
Document authorship, review, and approval of SOPs, reports, and quality records
Oversight of investigation and CAPA program management
Supports internal audits, client audits and regulatory inspections, as needed
Other related duties as assigned

Required Skills and Abilities

Knowledge of GMP and FDA regulations for clinical trial materials preferred
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
Demonstrated experience in characterization and analytical techniques relevant to the pharmaceutical industry
Demonstrated experience with advanced laboratory and data analysis skills preferred
Strong analytical and problem-solving skills

Education and Experience

Minimum of a Bachelor's Degree, preferably in a scientific discipline
3+ years previous manufacturing, quality control, or quality assurance experience
Working knowledge of Veeva and/or SAP 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

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

Show full description