Technical Writer

BEPC has an open position for Quality Specialist/ Technical Writer in St. Louis, MO!
Contract W2 Period: 12 - month contract with possibilities for extensions
Pay & Benefits: $25.00 – 30.00/hr. Medical, Dental, Vision and Life Insurance

Description:

· Primary responsibility will be to write, revise, and/or review Standard Operating Procedures (SOPs) · Under minimal supervision, the Quality Specialist, Stability supports the stability program under regulatory requirements and ISO 13485 and runs stability studies from initial batch/lot selection to final report generation and study destruction · Works closely with Quality, R&D, and Operations to assure appropriate batch/lot
selection, initiation, and execution of Stability studies in a compliant and timely manner. · Support activities to ensure proper maintenance of the Rocklin stability program · Analyze and interpret laboratory/stability data · Draft, review, and update stability protocols upon revisions to specifications, or regulatory requirements · Generate/review stability study summary reports and verify associated source data · Own investigations pertaining to OOS and OOT stability results and/or deviations · Perform impact assessment of temperature/humidity excursions · Escalate to Quality management any out-of-trend or out-of-specification data immediately upon discovery · Accurately document all activities with adherence to cGMP and company standards · Maintain work area and documentation in a neat and organized manner · Work with computers as well as laboratory software, or proprietary software as needed · Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to management · Write, revise, and/or review Standard Operating Procedures (SOPs) · Adhere to SOPs and GMP regulations and policies · Support internal and external audits as required · Maintain current training requirements · Meet productivity standards without sacrificing quality and safety · Adhere to established safety procedures; use equipment and materials properly · Understand, support, and communicate Company mission, vision, and values · Work on weekends or extended hours as needed · Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual

Requirements:

· BS or MS in Chemistry/Biochemistry, Biology or related field · Minimum 3 years of experience working in a regulated environment which includes stability · Experience working in ISO 13485 and/or FDA regulated environment · Experience in IHC preferred · Experience with SAP and/or SAP NEXT strongly preferred · Good computer skills, including Microsoft 365 · Good organizational and time management skills · Ability to work independently and manage multiple priorities with attention to detail · Strong technical writing skills · Strong technical, analytical, and problem-solving skills · Experience working in ISO 13485 and/or FDA regulated environments · Knowledge of SAP and/or SAP NEXT strongly preferred

Job Type: Contract

Pay: $25.00 - $30.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Schedule:

• Day shift

Experience:

• Microsoft Powerpoint: 1 year (Preferred)

Work Location: In person

Salary : $25 - $30