Quality Technician II

---

Job description

POSITION SUMMARY:

Support Quality Assurance (QA) functions in the receipt and release of materials as well as maintaining records in support of manufacturing and quality.

DUTIES AND RESPONSIBILITIES:

* Monitor temperature charts and data loggers and ensure timely notification of excursions
* Lot Status Identification: Maintain up-to-date Release Pass/Hold/Fail tags on all inventories intended for customers or related to Quality testing, and ensuring correct physical location of inventory in Quarantine or on Hold
* Inventory and cycle counts on QC testing materials
* Inspect and receive incoming raw materials and file associated paperwork
* Perform physical inventory and cycle counts activities for quarantine areas
* Assist in identifying and developing work processes to improve quality and efficiency of the disposition, batch record review and incoming inspection processes.
* Review batch records and associated documentation (e.g. NCMRs, Deviations) for adequacy prior to product disposition. Work with internal customers to resolve any documentation issues.
* Author Certificate of Compliance (COC) for MSD products
* Record, archive, and retain records pertaining to activities performed following GDP and retention procedures
* Review and update specification documents to improve quality and efficiency. Specific duties may vary depending upon departmental requirements
* Train Quality Technicians on procedures, protocols and Operational Quality practices
* Specific duties may vary depending upon departmental requirements

EXPERIENCE AND QUALIFICATIONS:

* Associate's degree in Biochemistry, Microbiology, or Chemistry or related field is required.
* 1 to 3 years of experience in biotechnology, diagnostic or regulated quality assurance is required.

o Bachelor's degree in biochemistry, microbiology, chemistry related field may be substituted for experience.

* Experience reviewing and understanding basic chemical nomenclature
* A demonstrated level of consistency in performance and aptitude for managing additional responsibility and accountability are required for next level consideration

KNOWLEDGE, SKILLS AND ABILITIES:

* Demonstrated understanding of basic scientific principles and measurements
* High level of attention to detail, highly motivated and organized
* Strong analytical, communication and interpersonal skills are a key element to success in this role
* Proficiency in MS Office applications as well as a capacity to learn additional software applications as the need arises
* Ability to work independently in a fast paced environment

o A wide degree of creativity and latitude is expected including the ability to multi-task in an environment with changing priorities

PHYSICAL DEMANDS:

* Lift up to 25 lbs
* There are aspects of the positions duties that require a person in this role to work at heights of six (6) feet on occasion
* Ability to perform pipette transfers
* This position requires working with a computer or other items that will require fine motor manipulation

WORK ENVIRONMENT:

* Standard wet lab environment
* Standard office environment

<!– job description page –>