Quality Control Associate

Roche; United States; On-site; USD 60,000 - 90,000; Full time

Job summary

Roche in the United States seeks a Quality Control Associate to perform raw material and finished goods testing, review and sign-off quality documentation. You will work in an ISO 13485 and cGMP manufacturing environment, maintaining equipment, records and the laboratory environment to ensure regulatory compliance with SOPs.

The role involves investigating Out of Specification results, maintaining traceable records, and supporting continuous improvement while coordinating with cross-functional

Qualifications

• Experience performing inspection and testing of materials and finished goods.
• Ability to document test results and generate batch records.
• Familiarity with regulatory requirements (FDA, QSR, ISO) and GMP practices.

Responsibilities

• Perform inspection and testing of raw materials, in-process materials and finished goods in a compliant manner.
• Document test results, complete batch records, document observations and generate reports for qualification testing.
• Conduct data analysis of raw material, in-process and finished goods test results.
• Responsible for generating compliant QC documentation as part of the Device History Record required for releasing items into inventory from the raw material to the in-process finished goods.
• Maintain records and QC lab environment to comply with cGMP, OP and regulatory requirements.
• Performs routine maintenance of laboratory equipment outlined by operating procedures.
• May assist in coordinating vendor activities for user maintained laboratory equipment.
• Perform regular laboratory and manufacturing environmental monitoring testing.
• Formulate reagents with high complexity for material testing process.
• Acts as QC representative in transferring processes from development to QC.
• May assist in testing raw materials for reliability and stability,in process monitoring and trending,in collecting, interpreting and communicating process metrics for recommended improvements.

Skills

Quality control

Documentation

Regulatory compliance

OOS investigations

Tools

Laboratory equipment

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The Opportunity:

The Quality Control Associate - will be an integral part of a team that performs raw material and finished goods testing. Will be responsible for review, generation and sign-off of quality documentation.

The ideal candidate will be responsible for interfacing with highly complex systems and controls in an ISO 13485 and cGMP manufacturing environment; maintain areas in high state of inspection preparedness by maintaining equipment, records and laboratory environment in order to comply with regulatory requirements utilizing current regulations and Operating Procedures (OP). Additionally, maintains production documents, investigates Out of Specification (OOS), and works independently with general guidance from senior team members.

Responsibilities :

• Perform inspection and testing of raw materials, in-process materials and finished goods in a compliant manner.
• Document test results, complete batch records, document observations and generate reports for qualification testing.
• Conduct data analysis of raw material, in-process and finished goods test results.
• Responsible for generating compliant QC documentation as part of the Device History Record required for releasing items into inventory from the raw material to the in-process finished goods.
• Maintain records and QC lab environment to comply with cGMP, OP and regulatory requirements.
• Performs routine maintenance of laboratory equipment outlined by operating procedures.
• May assist in coordinating vendor activities for user maintained laboratory equipment.
• Perform regular laboratory and manufacturing environmental monitoring testing.
• Perform and lab supply ordering and inventory management in order to support the QC laboratory and adherence to inventory control processes (TECO, Cycle counts, etc), including indirect materials, tissue kanbans, and retain samples.
• Formulate reagents with high complexity for material testing process.
• Acts as QC representative in transferring processes from development to QC.
• May assist in testing raw materials for reliability and stability,in process monitoring and trending,in collecting, interpreting and communicating process metrics for recommended improvements.
• Assist in performing, reviewing and/or generating validations for QC processes and laboratory equipment,in the development and implementation of testing processes, in reagent manufacturing activities unrelated to QC activities.

Quality and Safety, Compliance

• Maintains Right to Operate and ensures that all processes are performed in a safe and healthy manner; addresses and escalates any potentially unsafe hazards; Ensures timely reporting of safety hazards, incidents and near misses using safety reporting tools.
• Navigates and understands the quality system and escalates issues.
• Accurately performs tasks in a regulated environment (OSHA, NMPA, FDA, etc.).
• Performs and documents all transactions and production instructions with accuracy related to the proper receipt, quarantine, storage, and disbursement of materials as it relates to FDA, OSHA, QSR, ISO, Good Manufacturing Practices and other Roche policies and procedures.
• Ensures equipment is in compliance with calibration standards.
• Conducts out of specification (OOS) and supports non-conformance investigations, reworks, and corrective actions. Serve as a contact for other departments regarding QC related activities.
• Acts as QC representative in the review of and provides feedback on document changes, including redlines provided by external teams (Development, Operations Scientists, Design Transfer Operations, project teams, etc).
• Adheres to 95% or above internal training compliance.
• Maintains complete and accurate records including daily metrics.

Continuous Improvement

• Conducts 6S activities, gathers/meets cycle times and develops/follows standard work; identifies and implements process improvements and continuous improvement initiatives utilizing lean tools.
• Participates and contributes in team meetings.
• Participates in process improvement projects and in the collection of data for daily metrics purposes and to support operational excellence initiatives and improvements.

Teamwork and Collaboration

• Proactively collaborates with peers and with other functions to ensure targets are achieved.
• Assists in onboarding by conducting training of new employees and contractors.
• Provides suggestions to improve work processes and laboratory equipment.
• Engages in cross functional technical