Apply on Employer Site

Solvias · 1 day ago

Quality Assurance Associate II

Canton, MA

Full-time

Onsite

Senior Level

$70K/yr - $85K/yr

5+ years exp

Solvias is a global provider of chemistry, manufacturing, and control analytics to the life sciences industry. They are seeking a Quality Assurance Associate II to perform QA auditing activities, review documentation for compliance with regulatory guidelines, and support quality assurance functions. The role involves independent operation once fully trained and may include supervisory responsibilities.

CosmeticsManufacturingMedical DevicePharmaceutical

No H1B

Hiring Manager

Daejia C. Hood, MBA, NCCP, SPHR, SHRM-SCP

Responsibilities

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

Providing back-up support and assistance with other quality assurance activities

Reviewing all documentation for conformance to established procedures and regulatory guidelines

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

Preparation and execution of client, agency, and internal audits

Writing, issuance, and tracking of quality events, change requests, and CAPAs / root causes

Tracking, filing and securing all controlled documents and records in the QAU document control system

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

Qualification

QA auditing experienceCGMP/GLP complianceAnalytical chemistryElectronic quality management systemMicrosoft productsCommunication skillsAttention to detailTeamwork