Quality Associate II
B. Braun Melsungen AG, Irvine, CA, United States
You’re an important part of our future. At B. Braun, we protect and improve the health of people worldwide.
Position Summary
Our Quality Associate II will support raw material quality control by sampling incoming materials, performing routine physical and identification testing, and ensuring all results meet established specifications. Responsibilities include managing the raw material retention program, conducting daily instrument calibration and maintenance within a cGMP environment, and maintaining accurate, real‑time laboratory documentation to support quality release and audit readiness.
Responsibilities
Monitors manufacturing process verifications to ensure compliance with operating procedures and specifications.
Provides support for quality investigation, including initiation and supporting data for the resolution of quality issues.
Provides quality oversight over the Quality System, including reviews, reports, data (including metadata) and records generated to support the manufacturing and distribution of product.
Conducts timely quality review of associated data, including data utilized to support batch release, to meet business and operations requirements.
Assists in complying with regulatory requirements related to product safety and quality.
Ensures that procedures are being followed as outlined under FDA, ICH, standard methods and the Quality System requirements.
Reviews records to ensure data meets the industry requirements for data integrity.
Qualifications
High school diploma/G.E.D. or equivalent required; Associate's or technical degree preferred.
01–02 years related experience required.
Regular and predictable on‑site attendance.
Ability to work non‑standard schedule as needed.
Compensation
Hourly rate $28.41–$30.81, depending on skills, experience and training.
Benefits
B. Braun offers an excellent benefits package, including healthcare, a 401(k) plan, and tuition reimbursement.
EEO Statement
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Workplace Discrimination is illegal.
#J-18808-Ljbffr
Position Summary
Our Quality Associate II will support raw material quality control by sampling incoming materials, performing routine physical and identification testing, and ensuring all results meet established specifications. Responsibilities include managing the raw material retention program, conducting daily instrument calibration and maintenance within a cGMP environment, and maintaining accurate, real‑time laboratory documentation to support quality release and audit readiness.
Responsibilities
Monitors manufacturing process verifications to ensure compliance with operating procedures and specifications.
Provides support for quality investigation, including initiation and supporting data for the resolution of quality issues.
Provides quality oversight over the Quality System, including reviews, reports, data (including metadata) and records generated to support the manufacturing and distribution of product.
Conducts timely quality review of associated data, including data utilized to support batch release, to meet business and operations requirements.
Assists in complying with regulatory requirements related to product safety and quality.
Ensures that procedures are being followed as outlined under FDA, ICH, standard methods and the Quality System requirements.
Reviews records to ensure data meets the industry requirements for data integrity.
Qualifications
High school diploma/G.E.D. or equivalent required; Associate's or technical degree preferred.
01–02 years related experience required.
Regular and predictable on‑site attendance.
Ability to work non‑standard schedule as needed.
Compensation
Hourly rate $28.41–$30.81, depending on skills, experience and training.
Benefits
B. Braun offers an excellent benefits package, including healthcare, a 401(k) plan, and tuition reimbursement.
EEO Statement
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Workplace Discrimination is illegal.
#J-18808-Ljbffr