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Quality Assurance/Quality Control (QA/QC) Analyst Job

Company Name:
Arca24.com
Salary period: Annual
QA/QC Analyst needed for a contract opportunity with Yoh's client located in Myerstown, PA.
Top Skills You Should Possess:
- QA/QC
- Master Batch records
- Manufacturing Execution System
What You'll Be Doing:
- Perform the analysis on raw materials, intermediates, and finished products, following prescribed procedures to provide the information base leading to raw material/intermediates/product disposition.
- Assist in troubleshooting and problem solving as directed. If assigned to the Microbiology area, focus is on micro testing. If assigned to the QA Compliance area, review in-process records and quality assurance test results for compliance with specifications and assign disposition. A Compliance role could also include responsibility for Master Batch Records (MBRs) within the Manufacturing Execution System (MES).
- Perform standard qualitative and quantitative analysis on: purchased raw materials, in-process products, pure drug substances and finished pharmaceutical preparations employing accepted gravimetric and spectrophotometer procedures, in accordance with approved testing procedures of BAYER, the National Formulary (NF) and the United States Pharmacopoeia (USP).
- Utilize standard "bench" chemistry technique as well as sophisticated electronic instrumentation, including spectrophotometer, viscometer, etc.
- Maintain records of all analysis information of assigned products on data sheets for permanent file and proper entry of information on laboratory forms.
- Evaluate all data obtained from analysis; if discrepancy or deviation occurs, consult with Supervisor and recommend additional testing if necessary.
- Perform routine analytical and microbiological testing of raw materials purchased from prospective suppliers to determine that the materials meet compendia and/or company standards.
- Adhere to the pertinent aspects of Corporate and plant safety programs and adhering to GMP's, ISO standards or other regulations.
- Assist in validation of manufacturing and production lines and equipment pertinent to chemistry and microbiology (eg equipment and room cleaning validation).
- If assigned to Microbiology, perform microbiological environmental monitoring in production areas and in the Microbiology Laboratory.
- If assigned to the QA Receiving area, develop specifications for packaging components and prepare final specification sheets for new, revised, or updated components in conjunction with packaging departments, other Bayer facilities and component vendors.
- If assigned to the QA Compliance area, audit all manufacturing and packaging documentation to ensure compliance with all GMP regulations and Bayer standards. Release bulk and finished package materials to ensure timely release to meet production requirements.
- If assigned to the Compliance area, may have a MBR focus to support conversion of paper batch documentation and creation of MBRs within MES.
What You Need to Bring to the Table:
- Bachelor's degree in Chemistry, Biology, Pharmacy, or related four (4) year science degree required.
- Knowledge, practical application, and understanding of analytical chemistry is necessary to perform the functions of this position
- This position is entry level into the Quality Assurance department and the incumbent will be expected to continuously learn Quality Assurance systems, manufacturing, and effectively engage in relationships with peers in the laboratories, Manufacturing/Production and personnel in other departments as needed.
Bonus Points! Otherwise Known As Preferred Qualifications:
- At least one (1) year of lab experience preferred
- if assigned to the lab, bench chemistry or lab experience preferred
- if assigned to the QA Compliance area, previous experience in validation and QA auditing would be preferred;
- if assigned to Microbiology area, previous experience in microbiology processes would be preferred.
Recruiter: Mary Nguyen
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: CLINICAL
MONJOB
J2WBRPHIL
Ref:
SFSF: LS

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