Technical Specialist, MQS
Description
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.
Minimum Qualifications:
- 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.
- Experience with writing QMS documents preferred.
- Expert experience in the use of MS Word.
Position Type/Expected Hours of Work:
This role is a full-time, exempt position. Days of work are Monday through Friday unless otherwise stated by the Supervisor or needed due to projects. Must be available to work holidays, weekends, or extended hours when needed.
Compensation:
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.
The compensation range for this role is $25.48 to $33.99 hourly, depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.