Quality Assurance Assistant

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 42,000 - 56,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, vision, and dental insurance

Health Savings Account (HSA)

Holiday/paid time off

Job summary

Fagron Sterile Services US (FSS) is seeking a Quality Assurance Assistant in Wichita, KS to ensure GMP-compliant manufacturing processes and to serve as reviewer/approver for required documentation in a plant setting.

The role is project-oriented with changing priorities and responsibilities, requiring experience in manufacturing or laboratory environments and proficiency in technical writing and review. Collaboration across teams is essential to maintain quality across multiple ongoing projects.

Qualifications

• High School diploma or equivalent; science degree preferred.
• Experience in manufacturing or laboratory setting.
• Experience in regulated environments (cGMP).
• Detail oriented with strong communication skills.
• Ability to work independently and with multiple departments.
• Ability to multitask and manage changing priorities.
• Cleanroom gowning trained or able to obtain qualification.
• Technical writing and document review experience.

Responsibilities

• Review lab data, validation and stability protocols/documents, batch records, specifications, and manufacturing orders for compliance.
• Support manufacturing through timely processing of deviations, change controls, CAPA, complaints handling, and investigations to ensure quality products.
• Conduct facility and/or supplier assessments, raw material release, and line clearances.
• Author and update SOPs as needed.
• Follow GMP guidelines and adhere to SOPs and GMP requirements.
• Communicate QA issues to employees and managers in a tactful manner.
• Work on multiple projects at once with changing deadlines and priorities.

Skills

Detail oriented

Strong verbal and written comm.

Independent and interdepartmental coll

Multitasking

Education

Associate or Bachelor's degree in science-related field

High School diploma or equivalent

Job description

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13619394

Who We Are

Since 1990, we've grown into a global leader in personalized medicine.

Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacific and are working together to support over 200,000 customers worldwide.

From compounding and natural products to software, equipment, and genomics we deliver smart, ready-to-use solutions that make healthcare better.

We're passionate, science-driven, and always looking for new ways to improve lives.

Explore your future at Fagron Career Site https://fagron.jobsmarket.site/pages/en-gb/jobs

About the Job

The Quality Assurance Assistant will ensure compliance of manufacturing processes in a GMP environment and will serve as reviewer and/or approver for required documentation in a plant setting. This position is very project-oriented, so the QA Assistant can expect every day to be different with changing responsibilities and priorities.

Key Responsibilities

• Review lab data, validation and stability protocols/documents, batch records, specifications, and manufacturing orders for compliance.
• Support manufacturing through timely process of deviations, change controls, CAPA complaint handling, and investigations to ensure quality products.
• Conduct facility and/or supplier assessments, raw material release, and line clearances.
• Author and update SOPs as needed.
• Follow GMP guidelines and adhere to SOPs and GMP requirements.
• Communicate QA issues to employees and managers in a tactful manner.
• Work on multiple projects at once with changing deadlines and priorities.

Basic Qualifications

• High School equivalent is required, associate or bachelor's degree in a science related field is preferred.
• Experience working in a manufacturing or laboratory setting.
• Ability to work in a regulated environment (cGMP).
• Detail oriented.
• Ability to work both independently and interdepartmentally.
• Ability to multitask.
• Ability to be cleanroom gowning trained and ability to maintain gowning qualification.
• Strong verbal and written communication skills.
• Technical writing and review ability.

What's on Offer?

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you'll have plenty of chances to grow both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

We're proud to be an equal opportunity employer. Diversity makes us stronger, and we're committed to creating an inclusive workplace where everyone feels welcome.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.