Job description
QC Reviewer/Technical Writer
Company: Frontage Labs., Inc.
Division/Department:
Reports to:
Full-time
Location:
Job/Req. QC reviewer/technical writer
Job Summary
QC Coordinator/Technical Writer:
1) Preparing study archiving materials for completed studies.
2) Reviewing result tables against data packages
3) Preparation/review of assay/validation plans, reports, and methods.
4) Management of Bioanalytical documentation
5) Review of Data Transfer Agreements and work on Data Reconciliations.
6) Use StudyDoc to generate report templates and prepare Watson result tables
7) Client/FDA Audit Support
Essential Duties & Responsibilities
List below the major areas of responsibility of the job in descending order of importance (most important to least important). Indicate the approximate percentage of time spent on each responsibility (note the total of all percentages must equal 100%, 3-5 responsibilities is normal but may vary). Under each responsibility, summarize the specific duties required to perform the job. Provide as much detail as necessary to fully explain the job and consider:
- Whether the reason the job exists is to perform that function and whether removing the function would fundamentally change the job.
- Whether serious consequences would arise if someone in this job is not required to perform a particular function/s.
- The number of employees available to perform the function or among whom the function can be distributed; and,
- The degree of expertise or skill required to perform the function.
% of Time
Duties & Responsibilities
10%
Preparing study archiving materials for completed studies.
10%
Reviewing result tables against data packages
10%
Preparation/review of assay/validation plans, reports, and methods
5%
Management of Bioanalytical documentation
10%
Review of Data Transfer Agreements and work on Data Reconciliations
50%
Use StudyDoc to generate report templates and prepare Watson result tables
5%
Client/FDA Audit Support
100%
Minimum Job Requirements & Qualifications
Describe the minimum level of formal education and experience required to successfully perform the job
as well as any required certification, licensure or registration. KSAs may include language requirements, required computer ability, communications skills, etc.
as well as any required certification, licensure or registration. KSAs may include language requirements, required computer ability, communications skills, etc.
Educational/Training Requirement:
BS minimum
Experience:
6 months to 1 year
Licenses/Certifications (if applicable) :
- NA
Knowledge, Skills, and Abilities (KSAs):
- skills to use Microsoft Office
Supervisory Responsibility
List the job titles that directly report to this job (formal supervision).
- NA
Travel Requirements
Estimate the percentage and nature (i.e., domestic or international) of travel; if no travel is required, indicate 0%).
NA
Americans with Disabilities Act (ADA)
PHYSICAL DEMANDS and work environment CHECKLIST
PHYSICAL DEMANDS
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. These may include lifting, pushing, climbing, degree of eyestrain, sitting for extended periods of time, prolonged standing, etc. Frequency refers to the amount of time one is engaged in the activity; please estimate time by checking the appropriate boxes.
Physical Demands
Physical Demand
None
Rarely
Occasionally
Frequently
Constantly
Weight
Standing
x
Walking
x
Sitting
x
Lifting
x
Choose weight
Carrying
x
Choose weight
Pushing
x
Choose weight
Pulling
x
Choose weight
Climbing or balancing
x
Stooping, kneeling, crouching
or crawling
x
Reaching with hands/arms
x
Using hands to finger, handle, grasp or feel
x
Talking
x
Hearing
x
Tasting or smelling
x
Repetitive motions
x
Seeing
x
Note: Any special physical demands should be clearly communicated to any applicants applying for this job and all employees occupying this job.
Does this job have any special vision requirements? Check all that apply.
Close vision (clear vision at 20 inches or less)
Distance vision (clear vision at 20 feet or more)
Color vision (ability to identify and distinguish colors)
Peripheral vision (ability to observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point)
Depth perception (three-dimensional vision, ability to judge distances and spatial relationships)
Ability to adjust focus (ability to adjust the eye to bring an object into sharp focus)
x
No special vision requirements
WORK ENVIRONMENT
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Describe in the box below:
If a job is required to work or irregular hours (overnight, weekends, overtime, etc.);- Any hazardous or unusual conditions associated with the physical environment this job works in (outside, in inclement weather, exposure to toxic materials, etc.);
- Other unusual working conditions like extreme deadlines, pace of work, noise, etc.; and,
- How often or for how long someone in this job is exposed to these conditions.
The statements herein are intended to describe the general nature and level of work being performed by Employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the Company's discretion. To perform this job successfully, an individual must be able to perform each essential duty, either with or without reasonable accommodation.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
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