Quality Assurance Associate II

Recruiters please do not contact this job poster. Please be advised: Solvias does not accept unsolicited resumes or services from third-party recruitment agencies. In the event, a recruiter or agency submits a resume or candidate without an agreement we shall explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to Company employees, shall be deemed the property of the Company.

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards.

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, and the like; reviewing all documentation for conformance to established procedures and regulatory guidelines; providing back-up support and assistance with other quality assurance activities (e.g., monitoring, monthly approvals, pharmacy functions and other quality systems) as necessary; and reviewing all documentation for conformance to established procedures and regulatory guidelines. An employee in this position will be expected, when fully trained, to operate independently. This position may also 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, as necessary.
• Ensuring that work conforms to appropriate regulatory requirements, including SOPs, US FDA and cGMP/GLP.
• Support QAU Management in the review of protocols and reports for cGMP/GLP compliance; in the preparation and execution of client, agency, and internal audits; and for the writing, issuance, and tracking of 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.
• Responsible for tracking, filing and securing all controlled documents and records in the QAU document control system and auditing 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 of questions related to laboratory operations and client correspondences.
• Strict adherence to Solvias USA, LLC Safety Program.

Requirements

• BA/BS degree in a scientific area of study (chemistry is preferable), and 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.