Technical Specialist, MQS

Avid Bioservices • Tustin, CA

2d • $25 - $34

About The Position

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Technical Specialist, MQS is responsible for writing records for Avid’s Quality Management System (QMS) including, but not limited to, records for the following: Deviations, out-of-tolerance calibration events, out-of-specification (OOS) results, out-of-limit (OOL) results, and out-of-trend (OOT) results. This role performs investigations required to write these records and for routing/tracking records from assignment to approval. Identifies and implements corrective and preventive actions (CAPAs), as applicable. Where issues or improvements are identified, this role works with subject matter experts to propose viable solutions including a final product impact assessment. Identifies elements that can be made more efficient, are potential sources of discrepancies, require ‘fine-tuning’, or need a complete revision. Adhere to Good Manufacturing Practice (GMP) regulations (21 CFR, Part 211) and Good Documentation Practices (GDP), as applicable. 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. Adhere to rules for correct grammar, usage, and mechanics; write clear and understandable text, using a narrative approach where applicable; revise based on redlines and comments from subject matter experts, management, and QA. 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. Ability to perform statistical analysis of data to form conclusions and recommendations. Other tasks as assigned.

Requirements

• B.S. degree in science or engineering (biological, chemical, or biomedical.
• 2+ years of technical writing experience, or an equivalent combination of relevant education and experience.
• Excellent technical writing skills.
• Expert experience in the use of MS Word.

Nice To Haves

• Experience with writing QMS documents preferred.

Responsibilities

• Writing records for Avid’s Quality Management System (QMS)
• Performing investigations required to write records and for routing/tracking records from assignment to approval
• Identifying and implementing corrective and preventive actions (CAPAs), as applicable
• Working with subject matter experts to propose viable solutions including a final product impact assessment
• Identifying elements that can be made more efficient, are potential sources of discrepancies, require ‘fine-tuning’, or need a complete revision
• Adhering to Good Manufacturing Practice (GMP) regulations (21 CFR, Part 211) and Good Documentation Practices (GDP), as applicable
• Investigating root causes of a variety of events
• Writing QMS records with excellent attention to detail
• Adhering to procedures that define requirements for each record type
• Adhering to rules for correct grammar, usage, and mechanics
• Proactively interfacing with witnesses and subject matter experts to gather information
• Interfacing with Quality Assurance (QA) on questions related, but not limited, to: GMP compliance, Avid procedures and processes, investigation requirements, and record quality and style
• Managing each record from the time it is assigned through closure
• Managing multiple records and projects simultaneously
• Performing statistical analysis of data to form conclusions and recommendations
• Other tasks as assigned

Benefits

• We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
• Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees