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Technical Specialist, MQS
Avid Bioservices
Tustin, USA
Full-time
Entry
Onsite
USD 54400-68000 yearly
Discovered 1 weeks ago
Free
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- 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.
- 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.
- 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.
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