Quality Management Systems (QMS)

BioTalent; Tustin (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

BioTalent seeks a Technical Specialist, Quality Management Systems (QMS) in Tustin, CA to support quality investigations, technical writing, and QMS documentation activities. This role contributes to GMP compliance by documenting quality events and driving CAPAs and records closure.

The successful candidate will collaborate with QA, SMEs, and cross-functional teams, ensuring accurate records, adherence to GDP, and timely closure of investigations across multiple projects.

Qualifications

• 2+ years of technical writing experience or equivalent.
• Familiarity with GMP regulations, quality management systems, and root cause analysis methodologies.
• Experience with writing QMS documents preferred.

Responsibilities

• Adhere to GMP and GDP as applicable.
• Investigate quality events including deviations, OOS/OOL/OOT, and calibration issues.
• Identify root causes using procedures, reports, batch records, and data.
• Write QMS records with accurate, fact-based documentation.
• Interface with witnesses, SMEs, and QA on investigations and records.
• Manage records from assignment to closure within timelines.
• Manage multiple records and projects concurrently.

Skills

Technical writing

GMP knowledge

Root cause analysis

QMS documentation writing

Education

B.S. degree in Biology, Chemistry, Biomedical Engineering, Chemical Engineering, or a related scientific discipline

Job description

Technical Specialist, Quality Management Systems (QMS)

Location: Tustin, CA

About the Role

We are partnering with a leading biologics contract development and manufacturing organization (CDMO) focused on advancing innovative biopharmaceutical therapies. They are seeking a Technical Specialist, Quality Management Systems (QMS) to support quality investigations, technical writing, and quality system documentation activities. This role plays a key part in maintaining GMP compliance by conducting investigations, documenting quality events, and driving corrective and preventive actions to support operational excellence and product quality.

Key Responsibilities

• Adhere to Good Manufacturing Practice (GMP) regulations (21 CFR, Part 211) and Good Documentation Practices (GDP), as applicable.
• Investigate quality events including deviations, out-of-specification (OOS), out-of-limit (OOL), out-of-trend (OOT), and calibration-related issues.
• Investigate root causes of a variety of events, with reference to related source documents including, but not limited to, procedures, protocols, reports, batch records, laboratory data, and calibration data; apply relevant scientific and technical principles during investigation.
• Write QMS records with excellent attention to detail; ensure records accurately present the facts determined during investigation.
• Adhere to procedures that define requirements for each record type.
• Proactively interface with witnesses and subject matter experts to gather information; interface with Quality Assurance (QA) on questions related, but not limited, to: GMP compliance, Avid procedures and processes, investigation requirements, and record quality and style.
• Manage each record from the time it is assigned through closure; work with all stakeholders to ensure record is closed according to defined timelines.
• Manage multiple records and projects simultaneously.

Qualifications & Requirements

• B.S. degree in Biology, Chemistry, Biomedical Engineering, Chemical Engineering, or a related scientific discipline.
• 2+ years of technical writing experience or an equivalent combination of education and relevant experience.
• Familiarity with GMP regulations, quality management systems, and root cause analysis methodologies.
• Experience with writing QMS documents preferred.

This position is not eligible for visa sponsorship or support such as H1B, TN, E-3, CPT, OPT, STEM OPT, or employment-based permanent residence processes, now or in the future.