Quality Assurance Associate II

Job Description

Solvias is an internationally recognized provider of integrated solutions in contract analytical research, development, and manufacturing. The company offers a broad spectrum of services and solutions in the Pharmaceutical, Biotech, Medical Device, Cell & Gene Therapy (CGT), and Cosmetic industries. With headquarters near Basel, Switzerland, about 800 highly qualified employees take pride in putting science at the heart of serving customers to bring safer and better products to market faster.

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 QAU Management.

• 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.
• 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.

Salary Range 70,000 – 85,000 USD

Requirements

• BA/BS degree in a scientific area of study (chemistry is preferable), and minimum of 2 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 North America 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.

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