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The Quality Control Associate - Reagent Manufacturing will be an integral part of a team that performs raw material and finished goods testing. The individual 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. The individual will 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, 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.
● Foster and follow an established safety culture, environmental guidelines and procedures for all work performed.
● 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,process monitoring and trending, and collecting, interpreting and communicating process metrics for recommended improvements.
● Assist in performing, reviewing and/or generating validations for QC processes and laboratory equipment,the development and implementation of testing processes and 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.
● Participates in the collection of data for daily metrics purposes and to support operational excellence initiatives and improvements.
● Other duties as assigned.
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.
Education Level Education Details Req Pref
High School Diploma - Required ( 5 -7 years of experience )
Associate's Degree - Preferred
Bachelor's Degree - Preferred
Knowledge, Skill or Ability Req Pref Proficiency
Required
- Excellent oral and written communication skills demonstrated by communicating with 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
Preferred
• Experience working in GLP, cGMP or ISO regulated environment
• Experience with 6S and Lean techniques
• Experience with handling corrosive and biohazardous reagents
Physical conditions and PPE requirements
● The environment requires gowning, hair net, safety glasses, gloves and foot coverings.
● Lifting up to 25lbs is required.
● Schedules could include overtime and shift work in the future as business needs require.
● Required to stand, walk, sit, kneel, bend, crouch for a combined 4 or more hours per day.
● Required to push, pull, and lift a minimum of 25 pounds. Repetitive, consistent movements of the wrists, hands, and/or fingers.
● Required to have good near visual acuity to perform activities throughout the processes in the assigned area.
Relocation benefits are not available for this job posting.
Pay transparency
The expected salary range for this position based on the primary location of Tucson is 49,300.00 - 91,500.00 USD Annual. 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 at the link provided below.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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