Analytical QA Associate -Fall River,MA
01-27-21 (04:02 AM)
Fall River, MA, UnitedStates
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 at InvaGen Pharmaceuticals, Inc.
This role will be part of the Cipla NY (Invagen) Quality Control (QC)/Analytical QA Team whose role is to ensure our patients receive medicine of the highest quality. We accept the trust patients place in us and we deliver quality medicines.
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 softwares such as “Empower”, “Potentiometry”, and other softwares used in an analytical laboratory setting.
- Prepare and review standard procedures in line with guidelines.
- Review and identify gaps within the system during routine monitoring and inform the supervisor of any potential areas of improvement within the identified areas.
- Conduct laboratory investigations and review incidences.
- Ensure compliance to all data integrity and cGMP practices, procedures, and expectations.
- Other specific duties and responsibilities as assigned.
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.