Pharmaceutical QA

Analytical QA Associate

Central Islip, USA

Full Time

Must have:

• Possess a bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master's degree in the above and/or related fields of study as noted above preferred.

• A minimum of two (2) years of relevant work experience in a pharmaceutical manufacturing setting within the Quality function.

• Experience using statistical software packages is a plus.

• Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.

• Current, working knowledge of quality assurance (QA).

• Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good Distribution Practices (GDP), etc.

JOB DESCRIPTION and PURPOSE:

• The purpose of this position is to serve as an Analytical Quality Assurance (AQA) Associate. This role will report to the Section Head of Analytical QA or other senior leaders in the Quality organization.
• The general duties and responsibilities of this role include but are not limited to the following:
• Verify analytical equipment, qualification/calibrations, and ensure compliance before usage.
• Review and ensure compliance of analytical documents related to in-process, finished product, stability studies, etc.
• Verify the validation processes and characterization.
• Execute and follow standard protocols.
• Utilize laboratory compliance software such as "Empower", "Potentiometry", and other software used in an analytical laboratory setting.
• Ensure compliance to all data integrity and cGMP practices, procedures, and expectations.
• Other specific duties and responsibilities as assigned.

QUALIFICATIONS

• The ideal candidate minimum qualifications will include:
• A Bachelor's degree (BS or BA) in Chemistry or related technical/physical science from an accredited college/university is required. A master's degree in a field to study relevant to the position is preferred.
• Not less than (NLT) two - five (2-5) years of relevant experience in Analytical QA.
• Experience working in pharmaceutical QA is preferred.
• Proficiently speak English as a first or second language.
• Proficiently communicate and understand (read and write) scientific / regulatory based 'work" in English.
• Have excellent organization, learning and teaching skills required to work in teams.
• Strong desire towards continuous improvement.
• Know how to use Microsoft Office programs and other scientific based software.

WORKING CONDITIONS AND EXPECTATIONS:

• This role works in a current Good Manufacturing Practice (cGMP) office, laboratory, and manufacturing environment, where personal protective equipment (PPE) may be required, which may include uniforms, lab coats, safety glasses, respiratory PPE, hearing protection, etc.
• Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility may be required.
• Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period may be required.

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