Posted on: April 10, 2021
Description:The primary purpose of the QC Specialist is to
perform review of all raw analytical data in laboratory notebooks,
forms, worksheets, and logbooks. This review is to ensure that the
various compounds and components were tested correctly according to
compendial monographs, internal analytical methods, internal
specifications, client procedures, and miscellaneous research
procedures as required in internal SOPs. In addition, the QC
Specialist may also assist in review of protocols, summary reports,
SOPs, internal analytical methods and internal specifications to
ensure the document is accurate and complete. The QC Specialist
will also help create CoA's, track QC audit observations and make
sure corrective actions are completed and any other miscellaneous
tasks as assigned.ESSENTIAL JOB FUNCTIONS:
- Reviews laboratory notebooks, forms, and logbooks.
- Performs review of any internal methods, specifications and
protocols to ensure compliance or accuracy.
- Assists with drafting protocols, summary reports and new or
existing internal procedures or specifications.
- Create/Amend Certificate of Analysis
- Assists with administrative support activities such as
maintaining files and processing paperwork.
- Coordinates/assists in change and process improvements
- Coordinates and tracks client and regulatory audit observations
to ensure timely closure.
- Maintains a cGMP laboratory notebook and forms.
- Follows all company cGMP practices, policies, and
- Follows all company safety practices, policies, and
- QA/QCAdditional Skills & Qualifications:Must Haves:
- Bachelor's degree in chemistry, biochemistry, biology or
related life science field required.
- 2+ years of experience in a cGMP pharmaceutical
- Must be detail orientedExperience Level:Entry Level About
Aerotek:We know that a company's success starts with its employees.
We also know that an individual's success starts with the right
career opportunity. As a Best of Staffing Client and Talent leader,
Aerotek's people-focused approach yields competitive advantage for
our clients and rewarding careers for our contract employees. Since
1983, Aerotek has grown to become a leader in recruiting and
staffing services. With more than 250 non-franchised offices,
Aerotek's 8,000 internal employees serve more than 300,000 contract
employees and 18,000 clients every year. Aerotek is an Allegis
Group company, the global leader in talent solutions. Learn more at
Aerotek.com.The company is an equal opportunity employer and will
consider all applications without regards to race, sex, age, color,
religion, national origin, veteran status, disability, sexual
orientation, gender identity, genetic information or any
characteristic protected by law.
Keywords: Aerotek, Madison , QC Specialist, Other , Verona, Wisconsin
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