Job description

Duties and Task

• Verify analytical equipment, and 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.
• 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 with all data integrity and cGMP practices, procedures, and expectations.
• Other specific duties and responsibilities as assigned.

Qualification for must

• Possess a bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a 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.

WORKING CONDITIONS

• 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.

Other details

• Relocation is negotiable.
• No employment sponsorship.
• No remote work is available.
• Must be willing to work long hours and some weekends based on a relevant business need, if required.

Job Type: Full-time

Salary: $65,000.00 - $85,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Relocation assistance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• How many years of working in a pharmaceutical company experience do you have?
• How many years of experience do you have as QA Associate?
• Do you have experience with analytical laboratory activities?
• List some of the analytical laboratory activities you have done.
• Do you have experience using statistical software packages?
• Are you US Citizen/ Green Card Holder? (No Visa Sponsorship)
• What is your expected annual salary for this position?

Education:

• Bachelor's (Preferred)

Work Location: One location

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