Diagnostic Quality Analyst
Responsible for quality control related activities within Diagnostics Manufacturing.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Performs QC testing, such as %CV testing of ELISA plates or HPLC assays
- Performs data analysis of QC results with ability to determine if material has passed or failed acceptance criteria
- Performs technical review and approval of Manufacturing Batch Records (MBR) and QC test results
- Assists in scheduling product line builds as needed
- Assists with manufacturing reagents and In-House material, such as Controls, Standards, ELISA plates, IFA slides, etc. as needed
- May manufacture and purify antigens. QC testing of material could include protein concentration determination, SDS gel, etc.
- Writes stability protocols, executes testing, and writes reports
- Assists in maintaining inventory of materials and supplies with cycle counts and requisitioning materials
- Organizes, maintains, and cleans QC areas
- Operates, maintains, troubleshoots, and possibly repairs equipment
- Writes or revises department specific documents and submits Document Change Requests (DCR) for documents
- Recognizes deviations and non-conformances (NCMRs) and completes required documentation
- Acts as Deviation, NCMR or CAPA owner
- Investigates issues with ability to identify root cause
- Generates reports/memos such as investigation reports, issue review, memos (amendments to release criteria, date extensions, etc.)
- Identifies and implements changes to reduce cost, improve product quality, improve product robustness, etc.
- Transfers new product or technology from Development to Manufacturing/QC
- Provides training, guidance, and leadership to department personnel
- Operates per cGMP and other applicable guidelines
- Abides by company rules, policies, and procedures
- Follows safety policies and procedures
- Works on special projects as assigned
This job has no supervisory responsibilities.
EDUCATION and/or EXPERIENCE
Position generally requires a Bachelor’s degree in a biological science or related field and 6+ years related experience. Knowledge and experience in pipetting, ELISA, HPLC and aseptic technique required. Experience in FDA, cGMP, CLIA/CAP environment highly preferred. Working knowledge of inventory control, quality control and quality assurance process preferred. Familiarity with ISO, MS Word, Excel, and statistics software programs is a plus.
Ability to read, understand and follow documents such as safety rules, equipment operation, maintenance instructions and laboratory procedures and recipes. Ability to analyze and interpret scientific data, regulatory documents, professional journals. Ability to write reports, correspondence, procedures and to create forms. Ability to clearly present information and respond to questions from employees, managers and vendors.
Understanding of and ability to use concepts of probability, statistics, fractions, percentages, ratios, and proportions in practical situations in the laboratory.
Strong problem solving and attentiveness to detail is required. Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Define problems, collect data and draw valid conclusions. Exercises judgment within defined procedures and practices to determine appropriate action.
CERTIFICATES, 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.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel. The employee is frequently required to stand, sit, and reach with hands and arms. The employee is frequently required to walk and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
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.
While performing the duties of this job, the employee is exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, potentially infectious body fluids and extreme cold.
The noise level in the work environment is moderate.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.