Job Description

Base Pay Range

$70,000.00/yr - $85,000.00/yr

Position Overview

An advanced level quality assurance position. Responsibilities include, but are not limited to: performing QA auditing activities that require a superior level of analytical and technical competency in auditing complex analyses; performing in?phase real?time audits; developing and conducting cGMP/GLP training events; reviewing all documentation for conformance to established procedures and regulatory guidelines; and providing back?up support with other quality assurance activities such as monitoring, monthly approvals, pharmacy functions, and other quality systems. The employee will be expected, when fully trained, to operate independently and may have supervisory responsibilities and additional projects as directed by Quality Assurance Unit (QAU) Management.

Critical Performance Areas

• Writing and reviewing SOPs and completing US EPA Good Laboratory Practices (GLP) and US FDA current Good Manufacturing Practices (cGMP) forms as necessary.
• Performing routine auditing, inspecting, reporting and other QA functions in support of cGMP/GLP analytical services.
• Ensuring that work conforms to appropriate regulatory requirements, including SOPs, US FDA, and cGMP/GLP.
• Supporting QAU Management in the review of protocols and reports for cGMP/GLP compliance; preparing and executing client, agency, and internal audits; and writing, issuing, and tracking quality events, change requests, and CAPAs/root causes.

Essential Job Functions

• Exhibit a basic understanding of analytical chemistry and regulatory compliance pertinent to the work being completed.
• Track, file, and secure all controlled documents and records in the QAU document control system and audit technically approved raw data and documentation associated with analytical testing and facility compliance with adherence to cGMP regulations.
• Effectively interact with management, senior staff members, co?workers, and external contacts.
• Act as deputy to QAU Management for addressing questions related to laboratory operations and client correspondences.
• Adhere strictly to Solvias USA, LLC Safety Program.

Requirements

• BA/BS degree in a scientific area of study (chemistry is preferable) and a minimum of 5 years of QA/auditing experience.
• Experience working in GMP or GLP environment.
• Familiarity with an electronic quality management system (e.g., MasterControl) is highly recommended.

Other Desired Skills/Abilities

• Experience in a CRO/CDMO is preferred.
• Ability to work in a team environment where timely delivery is essential and shifting priorities can be expected.
• Demonstrate familiarity with Microsoft products such as Word, Excel, PowerPoint, Outlook, Access, and Teams.
• Strong written and verbal communication skills and attention to detail.

NOTE: This job description is not intended to be all?inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer: Solvias USA, LLC does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

Seniority Level

• Associate

Employment Type

• Full?time

Job Function

• Science, Research, and Quality Assurance

Industries

• Pharmaceutical Manufacturing
• Biotechnology Research
• Research Services

Location: Cambridge, MA

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