QC Analytical Data Reviewer


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QC Analytical Data Reviewer

Fenton, Missouri Direct Job ID: 2010114489

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Description
QC Analytical Data Reviewer
Direct Hire
Location: Saint Louis, MO (Fenton)
Shift: 8 – 5 (M-F)
Job Description:
Coordinate with other Quality Control chemists, R&D researchers and formulation specialists to ensure high quality standards are always met.

Summary:
Follow cGMP, cGLP, and OSHA guidelines with regard to work practices and safety.
Review data, reports and Standard Operating Procedures (initial creation and revisions), as required.
Write, and revise Standard Operating Procedures (SOPs), as required.
Review and revise laboratory systems.
Lead laboratory investigations.
May be required to Analyze raw, intermediate, final product and stability samples per compendial guidelines
May be required to Qualify, calibrate, and maintain chemical laboratory equipment as well as general laboratory maintenance.
Other duties as assigned.

Skills Required:
Experience in USP analysis and review with HPLC and/or GC methods.
Experience preparing cGMP and other laboratory documents.
Proficient in chromatography software for analysis and review purposes.
Proficient in technical writing.
Proficient in leading and writing laboratory investigations.
Experience with cGMP and FDA regulations.
Excellent organizational skills.
Effective communication both verbally and written.
Proficient in Microsoft Word, Excel, and PowerPoint.

Education and Experience Required:
A Bachelor’s degree in Chemistry with a minimum of five (5) years of laboratory experience, preferably in the pharmaceutical industry; Master’s degree in Chemistry with a minimum of three (3) years laboratory experience, preferably in the  pharmaceutical industry; Ph.D. with a minimum of two (2) years laboratory experience preferably in a pharmaceutical industry.

Preferred Education and Experience:
5-10 years of experience in a Pharmaceutical GMP facility.
5-10 years of experience troubleshooting HPLC and GC.
Proficient in Chromeleon and Chemstation software.
5-10 years of experience with ICH, DEA, Head Space, and IC regulation knowledge.
General knowledge of microbiology, for review purposes.
USP, EP, BP and JP methods of analysis, all or some.
Experience in Nasal Spray analysis and review.


 
More Details

PDS Tech, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Founded in 1977, PDS Tech, Inc. is one of the nation's premier specialty staffing firms with 31 offices nationwide. We offer a full range of benefits including:

  • Health insurance
  • Paid holidays
  • Weekly payroll
  • Immediate 401(k) eligibility
  • Completion Bonuses
  • Training
  • Please note availability of benefits may vary by position

PDS specializes in Engineering and IT arenas including Aerospace, Defense, Electronics, Telecommunications, Automotive, and Energy just to name a few. Our reputation, track record, and years of continuous growth reflect the commitment to quality that our employees and clients experience first-hand. To find out more about PDS, please visit www.pdstech.com

$$$ PDS pays for referrals! $$$

We pay thousands each month in referral bonuses!
Contact a recruiter for details. To find one near you, take a look at where we are.

If you have questions, please click here to contact us.


PDS Tech, Inc. is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities.
If you need special assistance or an accommodation while seeking employment, please click here or call 1-800-270-4737 to contact us. We will make a determination on your request for reasonable accommodation on a case-by-case basis.

The law requires PDS Tech, Inc. to post a notice describing the Federal laws prohibiting job discrimination. For information regarding your legal rights and protections, please click on the following links: EEO is the Law and EEO is the Law Supplement

PDS Tech, Inc. will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. Please see the Pay Transparency Nondiscrimination Provision for more information.

As a Federal Contractor, PDS Tech, Inc. is required to participate in the E-Verify Program to confirm eligibility to work in the United States.
For information please click on the following link: E-Verify