Quality Control Associate

F. Hoffmann-La Roche AG; Tucson, Northern (AZ, KY); Hybrid; USD 49,000 - 92,000; Full time

Job summary

F. Hoffmann-La Roche AG in Tucson, AZ is seeking a Quality Control Associate to support raw material and finished goods testing. You will review, generate and sign off quality documentation while maintaining lab systems in a regulated ISO 13485 and cGMP environment.

The role includes data analysis, OOS investigations, batch records, and continuous improvement via 6S/lean techniques. On-site collaboration with cross-functional teams is essential for issuing compliant QC documentation.

Qualifications

• Experience in a GLP, cGMP or ISO regulated environment.
• Strong data-analysis and problem-solving abilities.
• Hands-on lab work with accurate pipetting and measurements.

Responsibilities

• Perform inspection and testing of raw materials, in-process materials and finished goods.
• Document test results, complete batch records, observe observations and generate reports.
• Conduct data analysis of test results and support QC documentation for DHR release.
• Maintain QC lab environment and equipment calibration per procedures.
• Support OOS investigations, non-conformances, and CAPA activities.
• Collaborate with cross-functional teams and train new staff as needed.

Skills

Communication skills

Data analysis

Laboratory work

Pipetting accuracy

Attention to detail

Lean / 6S

Teamwork

Problem solving

Regulatory awareness

Education

High School Diploma

Associate's Degree

Bachelor's Degree

Tools

Google Suite

Job description

### 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 activities such as quality investigations and product design transfer. ● Follows, updates, changes and edits, standard operating procedures. ● Work closely with diverse cross-functional teams, including vendors, planners, and various departments, to ensure seamless integration and achieve our objectives effectively. ● Assist in the execution of complex projects. ● May act as a proxy for the QC Leadership when required. Providing support to the QC team to ensure smooth operation and adherence to standards and communicate to cross functional teams.**Who you are:****Education and Experience:**High School Diploma **( mandatory )**, with 7 years of experienceAssociate's Degree, with 3 years of experienceBachelor's Degree, with 1 year of experience ( entry level )**Knowledge, Skill or Ability:**• Excellent oral and written communication skills demonstrated by communicatingwith other functions and management regarding resolving testing, investigations and theory• Strong data-analysis skills, with clear demonstrated understanding of analytical, troubleshooting and problem solving skills. Proven math skills • Hands on experience in a laboratory • Accurate and precise manual pipetting and measuring techniques • Demonstrated attention to detail and strong organizational skills • Ability to utilize Google suite and computer programs • Proven ability to meet deadlines and work under aggressive timelines • Demonstrated ability to work effectively in a team environment • Experience working in GLP, cGMP or ISO regulated environment • Experience with 6S and Lean techniques • Experience with handling corrosive and biohazardous reagents**This is an (on-site/remote) position.****Relocation benefits (are/are not) approved for this posting.**The expected salary range for this position based on the primary location of Tucson is $49,300.00 -$91,500.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed in this link.