Quality Assurance Officer II

The Opportunity

The Quality Assurance Officer II is responsible for ensuring that all TechLab® Inc. products meet the requirements of the quality system. This can include tracking product and reviewing documentation to ensure it complies with regulatory standards. The Quality Assurance Officer II reports to the Quality Assurance Manager or the QA Supervisor.

Key Responsibilities

• Issuing and reviewing MBRs in support of Production schedule.
• Issuing/confirming Lot Expiration Dates of Raw Materials, Components and Finished Products.
• Create, review and apply QA Release Labels.
• Review QC results detailed per SOPs, RMSs and PRSs.
• Ensure approved documents (MBRs, SOPs, TLFs) are issued and controlled.
• Ensure Controlled Records are controlled and easily retrievable.
• Initiating and verifying proposed changes as Document Circulation Requests (DCRs) and Sage Change Request (SCRs).
• Perform Visual Inspection of Raw Materials, Foil/ Label Inspection and AQL testing.
• Ensure Non-Conformities and CAPA are identified, investigated and controlled.
• Initiate Non-conformity documentation and determine the Quality Impact.
• Determine Quality Impact of Non-Conformities and Effectiveness of CAPAs.
• Deliver New Hire Training.
• Complete projects as assigned by QA Manager or QA Supervisor.

Required Qualifications

• High School Diploma or Associate's Degree plus 3 years in a controlled manufacturing environment
• OR Bachelor's Degree plus 2 years in a controlled manufacturing GMP/FDA environment
• OR Master's Degree plus 1 year in a controlled manufacturing GMP/FDA environment
• Experience working within a controlled quality system (e.g., ISO 9001, ISO 13485, IATF 16949, GMP, or similar)
• Experience reviewing and approving documentation accuracy, completeness, and compliance.
• Experience with quality systems, including document control and record management.
• Experience supporting CAPA activities.
• Experience leading investigations, conducting root cause analysis
• Experience reviewing manufacturing, packaging, or quality records.
• Ability to assess quality impacts and make product disposition decisions.
• Strong attention to detail.
• Critical thinking and problem-solving abilities.
• Demonstrated ability to exercise sound judgment and make risk-based quality decisions
• Ability to independently review records and make quality decisions.
• Strong organizational and record management skills.
• Ability to manage multiple priorities while meeting deadlines.
• Effective verbal and written communication skills.
• Ability to work cross-functionally with Production, QC, and other departments.

Preferred Qualifications

• Life Science degree preferred
• Experience in pharmaceutical, biotechnology, medical device, or diagnostic manufacturing.
• Understanding of FDA, GMP, 13485 requirements.
• Experience with change control systems.
• Experience training personnel on GMP procedures.
• Experience with ERP or electronic quality systems
• Experience supporting audits or regulatory inspections.
• Experience developing CAPAs, and verifying the effectiveness of corrective and preventive actions.
• Experience with supplier management, qualifying, evaluating, and communicating with suppliers
• Leadership and mentoring capabilities.
• Experience leading quality improvement initiatives.
• Strong presentation and training skills.
• Continuous improvement mindset.

Location and Work Policy

TechLab maintains a climate controlled environment for the job of Quality Assurance Officer 2. An employee in this position must be able to lift upwards of 30lbs. A typical workweek is Monday through Friday 8:00 to 4:30 or 8:30 to 5:00. Overtime is occasionally necessary with or without advance notice.