Qc Bioanalytical Analyst Jobs in Iowa

Education and Experience Minimum Requirements

Extensive hands-on experience performing relevant analytical techniques (HPLC, GC, FTIR).

Must have experience with EMPOWER.

Must have excellent data analysis skills with attention to detail and interpretation of results with a focus on continuous improvement.

5-8 years relevant experience in a cGMP pharmaceutical QC environment, or at least 2-5 years with a Master’s degree.

Independently perform assays under GMP, maintaining data integrity and ensuring compliance with company SOPs and specifications

Performs other departmental duties as assigned by management

1+ year(s) experience of lab experience

Physical requirements include stooping, standing, climbing and occasional lifting of up to 50 lbs

Good verbal and written communication skills

We are looking for professionals with these required skills to achieve our goals:

Perform testing following written methodologies and report results which are clear, defensible and right the first time.

Summarize data in support of management review meetings.

Previous experience working in a GMP environment (2-6 years) conducting analytical assays

Previous knowledge of HPLC and ICP-MS instrumentation

Specific duties and responsibilities of the QC Analyst include, but are not limited to:

Ability draft QC method validation protocols and execute the protocols, as necessary.

Conduct analytical assays on final API product and raw materials.

Other Knowledge, Skills, and Abilities:

Responsible for communicating atypical and out-of-specification results to laboratory management.

Works with supervisor to prioritize activities. Shifts prioritizes to meet business demands. Notifies management when timelines cannot be met.

pharmaceutical industry and with analytical chemistry knowledge. Experience working in a

Demonstrates an understanding of the applicable test methods and a familiarity with compendial testing requirements.

Works independently or in a team setting with minimal supervision. Is accountable for the completion of individual responsibilities.

Demonstrates knowledge and understanding of Pharmaceutical GMPs and excellent cGMP documentation skills.

In-depth understanding and adherence to the Quality System requirements established by the client.

Responsible for test record, raw data, and document review.

Ensure Good Documentation Practices (GDP) are followed on controlled documents.

Demonstrates full understanding of routine laboratory procedures.

Ensures procedures and policies are accurately followed by QC analysts.