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QC Technical Writer
$1,000 SIGN-ON BONUS
Verona, WI
Job Description
POSITION OVERVIEW
The QC Technical Writer will primarily assist the Quality Control Department by researching, creating, revising and assisting with overall maintenance of technical documentation such as protocols, standard operating procedures, analytical methods, forms, raw material and finished product specifications. These technical documents may be handled in Qumas ComplianceSP or manually per the applicable SOP. In addition, the QC Technical Writer may also be tasked to support laboratory notebook and data reviews as well as laboratory testing with short notice. This position reports directly to the QC Manager but requires collaboration with QC Leadership staff to ensure deadlines are met. Coating Place, Inc. pays a $1,000 Sign-On Bonus for new employees after completing one year of employment.
ESSENTIAL JOB FUNCTIONS
The QC Technical Writer must be detail orientated and possess strong written, organizational, and communication skills. Efficient communication with QC Leadership staff in order to prioritize document flow and occasional laboratory testing with minimal oversight is required. The QC Technical Writer may need to consult vendors, reference manuals and subject matter experts in order to gather information to produce a clear and concise document. The QC Technical Writer should possess the ability to understand the information gathered in order to produce, draft, and finalize technical documents consistent with current company policies. Furthermore, during QC Leadership’s review and approval of the technical document there should be minimal editing required. EDUCATION/SKILLS/KNOWLEDGE REQUIRED
- Bachelor’s degree in chemistry or other science related discipline.
- 2+ years’ experience in the pharmaceutical cGMP environment. (Approved training courses in cGMP and FDA regulations may be substituted for laboratory experience).
- Experience with using and troubleshooting analytical equipment such as HPLC, GC, and dissolution is desirable.
- Ability to establish and maintain effective working relationships with co-workers and other departments as needed.
- Good time management skills to complete assignments/projects in a timely manner with minimal or no supervision
- Exceptional organizational skills and a strong attention to detail required.
- Proficient in the use of Microsoft Office products.
- Familiar with navigating through and understanding the USP, FCC, EP and other regulatory resources.
- Basic knowledge of Qumas Compliance SP and Microsoft SharePoint desirable.
Job Summary
Start Date
As Soon As Possible
Employment Term and Type
Regular, Full Time
Hours per Week
40+
Salary and Benefits
$18.00 - $23.00/hr
Required Education
Bachelor's Degree
Required Experience
2+ years
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