QA Technician II

at  Thermo Fisher Scientific

EDUCATION:

• Associate’s or Bachelor’s degree required.

EXPERIENCE:

• 2+ years of related experience in cGMP and/or Quality Assurance is required.
• Experience in a GMP environment is preferred; equivalent experience may be accepted in lieu of a degree.

KNOWLEDGE, SKILLS, ABILITIES:

• Proficiency in Microsoft Office applications (Excel, Word, PowerPoint) with a willingness to learn new software.
• Strong written and verbal communication skills.
• Excellent organization, planning, multi-tasking, and time management skills.

PHYSICAL REQUIREMENTS / WORK ENVIRONMENT

• Position requires ordinary ambulatory skills and coordination to navigate office environments.
• Ability to stand, walk, stoop, kneel, and crouch for extended periods.
• Capability to manipulate light to medium weights (10-35 pounds).
• Arm, hand, and finger dexterity for prolonged typing and grasping tasks.
• Visual acuity for using a keyboard, operating equipment, and reading materials.
• Ability to sit, reach, talk, and hear for extended durations.
• Commitment to adhering to Occupational Health and Safety policies to maintain a safe and healthy workplace.

• Supporting the completion and documentation of batch records, memos, and related materials.
• Coordinating the storage and retrieval of all batch records from archives.
• Maintaining up-to-date database records related to batch record review, storage, and archival.
• Assisting in routine archiving and destruction of outdated records.
• Managing document storage and generating approved record copies for clients upon request.
• Documenting trends related to error classification, root causes, turnaround times, and outstanding records.
• Coordinating Standard Operating Procedures (SOPs), Work Instructions (WIs), and Forms.
• Collecting and analyzing quality data, running Trackwise queries, and preparing quality reports.
• Managing new or updated documentation from date stamping to filing.
• Developing and updating QA documentation, Pack-Out procedures, and work instructions.
• Creating, issuing, retrieving, reviewing, and archiving log books.
• Interpreting Quality Assurance standards to outline department policies and procedures.
• Supporting training for new colleagues in QA documentation and Pack-Out processes.
• Participating in investigations, audits, and drafting responses for audit observations and CAPAs.
• Assisting with Pack Out and QA Final Release on a regular basis.
• Participating in GEMBa & JDI walks
• Performing additional duties as assigned to meet business needs