QC Reviewer/Technical Writer

3 weeks ago

Exton, United States Frontage Laboratories Full time
Job DescriptionJob 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.

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

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