Quality Assurance Associate

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Job description

Quality Assurance Associate

About Emery Pharma

Emery Pharma is a Contract Research Organization that delivers customized solutions to accelerate life science innovation. Leveraging our scientific expertise and state-of-the-art equipment, we enable our clients to expedite their product development journey. We are true collaborators and innovators; we work alongside our clients to solve their toughest scientific challenges and streamline their goals. Our mission and vision at Emery Pharma is to help our client-partners "Save Lives and Save the Environment."

Position Overview

The Quality Assurance Associate will support the Director of Quality Assurance by maintaining the quality management system (QMS) within Emery Pharma. This individual will be part of a diverse team of analytical and bioanalytical chemists, synthetic chemists, and microbiologists to maintain GLP/cGMP compliance in the laboratory and on various projects.

Essential Job Functions

• Provide QA oversight for personnel and company activities in compliance with all regulatory requirements, company policies, values, and goals.
• Collaborate within the QA team to ensure consistency and efficiency for the department.
• Lead and manage site (internal and/or external) audit readiness activities to always ensure inspection readiness.
• Participate in various audit support roles across the business unit during audits as required.
• Work with area management to address audit findings, drive opportunities for improvement and address potential gaps/preventive actions.
• Write up deviations, non-conformances, CAPAs, OOS's, and laboratory failures.
• Evaluate published Regulatory Agency (e.g., FDA) guidance, changes to external standards, and audit findings to assess impact to take action to mitigate risk to the business.
• Write and maintain SOPs and other quality documents, training documents, maintaining equipment/instrument logs, and vendor qualification programs.
• Ensure the qualification and calibration status of all equipment and instruments.
• Work and assist with project directors on regulated projects.

Position requirements

Education and requirements:

• Bachelor's Degree (B.S.) in Chemistry, Engineering, Biology, or relevant scientific field is required, or equivalent relevant experience.
• 3+ years' experience in a GLP/cGMP (regulated) laboratory work environment.
• Demonstrate skills in conducting and documenting quality related investigations.
• Demonstrate attention to detail, strong oral and written communication, and interpersonal skills.
• Ability to proactively plan, organize, and function with minimal oversight.
• Knowledge/familiarity of the following will be considered a plus: 21 CFR parts 11, 58, and 210 - 211; ISO 17025; Chromatography (HPLC/UPLC); Mass spectrometry (LC-MS and/or LC-MS/MS); GC-MS; NMR.

The above is not an exhaustive list of experiences/expertise required/preferred for this role. Candidates are free to highlight any specialized experience/expertise/accomplishments in their CV/resume and/or cover letter that they believe will bolster the operations of this science-driven company.

COVID-19 Precautions

Emery Pharma requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Emery Pharma will consider requests for reasonable accommodations.

Company Benefits

*Competitive signing bonus

We are prepared to offer the candidate a competitive compensation and benefit package, including: 90% of health, dental, and vision premiums, 401k retirement plan with company contribution, flexible paid vacation plan, and monthly profit sharing.

Emery Pharma is an equal opportunity employer. We are interested in every qualified candidate who is eligible to work in the United States.