Quality Control Associate

*Remapping worker to new work order with updated WBS code **
**The Pay Rate for this onsite role is *****


Top 3 Desired Skills


**Analytical and problem solving
**Great communication and organization skills
**Able to lift 20-25 pounds and stand for long periods of time


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.
• 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.
• 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.
• May assist in process monitoring and trending.
• May assist in collecting, interpreting and communicating process metrics for recommended improvements.
• Assist in performing, reviewing and/or generating validations for QC processes and laboratory equipment.
• Assist in the development and implementation of testing processes.
• Assist 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.
• 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.
• 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


Education
High School Diploma
ssociates or Bachelor's Degree in Science or Life Science discipline


Experience
7 years work experience, preferably in regulated industry with HS Diploma
3 years work experience with an Associate's Degree.
Less than 1 year work experience, entry level with a Bachelor's Degree.


Knowledge Skills and Abilities :
• 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.
• Demonstrated ability to work effectively in a team environment.
• Ability to work in department and/or cross functional meetings and projects.
• Proficient ability to perform a wide range of moderate and high complexity laboratory techniques and their application (titration, spectroscopy, protein analysis, tissue testing, etc).


Preferred
• Experience with handling corrosive and biohazardous reagents.
• Experience working in GLP, cGMP or ISO regulated environments.
• Experience with 6S and Lean techniques.


Physical conditions and PPE requirements:
The physical demands described are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• 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.