Technical Writer

$41,600 - $41,600/Yr

Remedy Intelligent Staffing - Ormond Beach, FL

Full-time - Entry Level

Ormond Beach, FL

Administrative and Support Services

About the position

The Laboratory - Quality Control Technical Writer position is located in Ormond Beach and reports to the QC Supervisor. This role is essential in ensuring that the data generated in the Quality Control Laboratory adheres to cGMP (current Good Manufacturing Practices), USP (United States Pharmacopeia), and good documentation requirements. The successful candidate will work on both routine and non-routine laboratory projects as directed by the Quality Laboratory Management Team. In this position, the individual will be responsible for following cGMP and 21CFR 210 and 211 requirements for laboratory testing and investigations. This includes writing or reviewing protocols and reports related to the QC Laboratory, supporting the laboratory management team in Out of Specification (OOS) investigations, compiling data, and participating in various steps of the investigation process. The role requires a willingness to work overtime as needed and to manage non-routine projects as directed by the laboratory supervisor. Additionally, the candidate will be tasked with organizing and maintaining laboratory documentation, including system suitability, protocols, validations, and investigations. Effective interaction at various levels within the organization and with external contacts is crucial. The ability to quickly learn complex business processes and specialized terminology, as well as adaptability to a changing environment with shifting priorities, is essential for success in this role.

Responsibilities

• Follow cGMP and 21CFR 210 and 211 requirements for laboratory testing and investigations.
• Write or review protocols and reports that pertain to the QC Laboratory.
• Support laboratory management team in OOS investigations, compile data, and participate in different steps of the investigation process.
• Organize and maintain laboratory documentation such as system suitability, protocols, validations, and investigations.
• Interact effectively at various levels within the organization and with external contacts.
• Quickly learn complex business processes and specialized terminology.
• Work on non-routine projects as directed by the laboratory supervisor.
• Perform job duties in a compliant and safe manner.
• Adhere to testing and project deadlines as assigned by quality laboratory management.
• Escalate non-conformances and Out of Specification results in a timely manner.

Requirements

• Associate degree or B.S. or B.A - Science or Engineering Degree.
• Minimum 2 years of experience in a QC laboratory or equivalent.
• Effective verbal/written communication, interpersonal, and team-building skills.
• Excellent organizational, problem-solving, prioritizing, and follow-up skills.
• Ability to handle multiple tasks/projects simultaneously.
• Good computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint.
• Ability to learn and work with computer software such as SAP, Chromatography software, and spreadsheets.
• 4+ years of experience working in a cGMP environment.
• Experience working in an FDA regulated laboratory.
• Working knowledge of FDA 21 CFR part 210 and 211 requirements.

Nice-to-haves

• Working knowledge of Empower software.
• Microbiology experience.

Benefits

• Dental insurance
• Health insurance