Quality Specialist

Title: Quality Specialist/ Technical Writer

Location: Rocklin, CA

Duration: 12 months

Quality Specialist/ Technical Writer - primary responsibility will be to write, revise, and/or review Standard Operating Procedures (SOPs)

PRIMARY OBJECTIVE OF POSITION:

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.

JOB RESPONSIBILITIES:

• 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

• Other duties as assigned or required to support the business

EDUCATION & EXPERIENCE:

• BS or MS in Chemistry/Biochemistry, Biology or related field

• Minimum 3 years of experience working in a regulated environment which includes stability knowledge/experience

• Experience working in ISO 13485 and/or FDA regulated environment

• Experience in IHC preferred

• Experience with SAP and/or SAP NEXT strongly preferred

KNOWLEDGE, SKILLS & ABILITIES:

• 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