What are the responsibilities and job description for the Quality Control Analyst position at VIVOS Professional Services, LLC?
Title: Quality Control Analyst
Location: Portsmouth, NH (Onsite)
Duration: 12-Month Assignment
Pay Range: $30/Hr. to $32/Hr, on W2
Job Summary
The Quality Control Technical Transfer Analyst 3 will act as a team member of the Quality Control department to support production by contributing to the completion of technical transfer activities. The role will also participate in quality testing for customer in-process, final product testing, and stability studies when needed. The individual applies job skills and company policies and procedures to complete a variety of tasks of increased scope, works on semi-routine assignments where the ability to recognize deviations from accepted practices is required, and analyzes situations or data that require review of identifiable factors.
Key Responsibilities
Run test samples for In-Process, Lot Release, and Stability studies.
Run test samples for investigations, transfers, and validations.
Review assays.
Train others as needed.
Participate in projects such as method transfers, new instrument implementation, and method qualifications.
Apply Data Integrity principles in all aspects of work in compliance with company DI policies, guidelines, and procedures.
Perform assigned, complex, and/or varied tasks.
Perform other duties as assigned.
Quality Systems & Documentation
Work with Change Control, Deviations, CAPAs, Tasks, EICRs, and Investigations.
Write quality records including Deviations, CAPAs, Change Controls, and Test Methods.
Write GMP procedures and validation documents.
Execute software validation test scripts.
Software & Laboratory Systems
Use Microsoft Word, Excel, and PowerPoint.
Use laboratory computer systems.
Utilize GMP quality systems such as TrackWise and LIMS.
Experience with SoftMax Pro, Empower, and SoloVPE.
Act as a Subject Matter Expert (SME) for at least one software system.
Technical & Analytical Responsibilities
Interpret data independently and with guidance.
Perform technical root-cause analysis for software errors.
Communicate with cross-functional teams to interpret needs and priorities.
Exercise judgment within defined procedures and practices to determine appropriate actions.
Required Skills & Competencies
Strong public speaking ability.
Strong written and verbal communication skills.
Prioritization and problem-solving skills.
Ability to comprehend and follow instructions.
Ability to direct, control, and plan tasks/projects.
Brainstorming and collaboration skills.
Self-motivated team player.
Ability to relate to others in a team setting.
Maintain a positive attitude in a team environment.
Demonstrate timeliness in completing assigned tasks.
Complete assignments accurately and on time.
Display commitment to quality and perform job functions to the best of his/her ability.
Experience Requirements
GMP experience within the pharmaceutical industry.
Experience with software validations including writing GMP procedures, validation documents, and executing test scripts.
Experience with Change Control, Deviations, CAPAs, Investigations, and related quality systems.
Experience using TrackWise, LIMS, SoftMax Pro, Empower, and SoloVPE.
Education
Associate’s Degree in Microbiology, Biochemistry, or a related Science field.
Additional Requirement
Must work the entire assigned shift, including arriving on time.a
Salary : $30 - $32