Purpose of the Position:
The Reagent QC Associate I is responsible for general laboratory duties focused on Quality Control of standards, controls and panels for commercially available nucleic acid tests and other advanced reagents. The Reagent QC Associate I will work under the direction of the Quality Control Supervisor and is expected to follow standard operating procedures and quality systems documentation.
Essential Duties and Responsibilities (other duties may be assigned):
- Compiles and submits manufacturing QC data and batch records for QA review and approval
- Coordinates and executes reagent manufacturing Quality Control procedures
- Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures
- Assists in inventory management and ordering materials
- Assists in the development of reagent manufacturing QC processes and documentation
- Assists in maintaining production and laboratory equipment
- Assists in the development of physical quality specifications and tests
- Assists in testing raw materials for reliability and stability
- Assist in transferring processes from development to manufacturing
- May assist in process scale-up to transition from pilot lots to full production-scale manufacturing
- Complies with ISO 13485 and cGMP standards.
- Supports continuous quality improvement
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Proven ability to deliver productivity to plan
- Must have excellent communication skills (listening, written, verbal, presentation)
- Strong technical skills, including a working understanding of molecular biology and biochemistry
- Demonstrated analytical, troubleshooting, and problem-solving skills
- Proven math skills
- Experience with Microsoft Word and Excel
- Demonstrated attention to detail
- Strong written and verbal communication skills
- Proven ability to meet deadlines and work under aggressive timelines
- Demonstrated ability to work effectively in a team environment
- Accurate and precise manual pipetting and measuring techniques
- Experience working with automated dispensing equipment is preferred, but not required
Education and Experience:
BS in molecular biology or related field with at least 2 years of hands-on experience in reagents manufacturing. Master’s degree in one of the related fields is preferred.
Must be proficient in writing and communicating in the English language including presentation of data and results. Computer literate with a working knowledge of Microsoft Word and Excel.
Must be consistent with level education.
Good problem solving, judgment and decision-making skill are required. High degree of organizing skill, planning skill, prioritization skill. Multitasking ability.
Certifications, Licenses, Registrations:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.