Our goal is to redefine IT staffing by embracing diversity and inclusion, connecting clients with exceptional and skilled professionals who bring innovative solutions while fostering an environment where every individual feels valued and empowered to thrive.
Quality Control Associate
Type: Contract, W2 only
Duration: 12+ months
Location: Tucson, AZ
Pay: $25.75/hr
Please note that at this time we are unable to sponsor employment authorization (both new and transfer)
The Quality Control Associate - Reagent Manufacturing will be an integral part of a team that performs raw material and finished goods testing. They will be responsible for review, generation and sign-off of quality documentation as well as 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).
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.
Qualifications:
- High School Diploma, Associates or Bachelor's Degree in Science or Life Science discipline
- 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.
- 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.
- Ability to utilize Google suite and computer programs.
- Proficient ability to perform a wide range of moderate and high complexity laboratory techniques and their application (titration, spectroscopy, protein analysis, tissue testing, etc).
- Experience with handling corrosive and biohazardous reagents (preferred).
- Experience working in GLP, cGMP or ISO regulated environments (preferred).
- Experience with 6S and Lean techniques (preferred)
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.
We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs.