Quality Assurance Associate

SGS_JOB_2513

Engineering
 North Carolina
Quality Assurance
Validation
GMP
CAPA
Engineering

Contract - 6 Months

Location (mandatory): Sanford NC USA 27330 The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation.

Job Responsibilities:

  • Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.
  • Provide QA review and approval for commissioning/qualification/validation documents.
  • Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions.
  • Work collaboratively with other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP principles including the underlying rationale of those principles.
  • Author, review and approved controlled documents for the Quality organization and other GMP functional areas including SOPs, specifications, protocols, and reports.
  • Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed.

Skills:

  • Strong knowledge of risk-based approach to qualification and validation activities in a Biotech Quality environment.
  • Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
  • Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices.
  • Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects.
  • Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
  • Excellent problem-solving skills and experience with root cause investigations and CAPA determination.
  • Advanced computer skills.
  • Off hours coverage and flexibility may be required.

Education/Experience:

  • B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 3-5+ years of experience or M.S. degree and 1-3+ years of experience in a QA function in a biologics manufacturing facility

Related Jobs

Data Scientist

Engineering
 Massachusetts
3 years

Location (mandatory): Lexington MA Designs, develops, and implements methods, processes, and systems to consolidate and analyze diverse data sets including structured and unstructured. Develops software programs, algorithms, dashboards, information tools, and queries to clean, model, integrate and evaluate datasets. Keeps abreast of new analytic methodologies and technologies. Collaborates with functional business units to drive business solutions and direction. Group develops human-centered technologies to overcome operational challenges and to enhance human capability in domains of interest to national security. Our team is seeking a candidate with expertise in Generative AI to join our research and development group, focused on advancing machine learning solutions for large-scale text processing. In this role, you will collaborate with interdisciplinary teams to design, implement, and optimize range of AI/ML/NLP/GenAI processes. You will apply your expertise in machine learning algorithms, data science, and high-performance computing environments(e.g., supercomputers) to create robust, scalable AI applications that address complex language learning-related challenges

Python
NLP
AI/ML
GenAI

Linguist III

Engineering
Remote
6 Months

The main function of a Linguist is to develop annotation workflows to assess product quality and analyze datasets, providing insights to XFN stakeholders.

Linguist
SQL
Python

Application Engineer

Engineering
 Massachusetts
6 Months

Location (mandatory): Andover MA Seeking a skilled engineer to deliver high-quality designs and testing in accordance with project specifications, standards, budgets, and timelines. This role involves providing centralized software support for critical BMS applications. The successful candidate will collaborate with a team to design, install, commission, and service building automation and facility management systems.

BMS
PLC
SACADA

Developer V

Engineering
 California
80-85/Hr on w2
12 Months

Location (mandatory): Sausalito CA We are looking for a Technical Game Developer to help invent the future of digital presence. In our Sausalito location, you will partner with our Creative Director, technical artists, research scientists, and engineers to create immersive demos that show how our state-of-the-art technologies can enable the future of AR/VR avatars. Our research team develops the technologies that will enable our product groups to ship the avatars the world will see in 5 to 10+ years. You’ll work in small, nimble teams to rapidly iterate on digital character-focused demos and prototypes.

C++
Unity
Maya

RF/Microwave Design Engineer

Engineering
 Massachusetts
3+ years

Location : Lexington, MA 02421, United States (Hybrid – Onsite 4 days/week, 1 day remote, 15% domestic travel) Senior RF/Microwave Design Engineer role supporting mission-critical defense projects. The candidate will design, develop, and test RF/microwave systems, circuits, and antennas while applying expertise in DSP, embedded systems, and cybersecurity. This position requires an Active Top Secret/SCI clearance, on-site presence (4 days/week), and up to 15% domestic travel.

RF/Microwave Design
Antenna Design
DSP
Embedded Systems
Signal Processing
C/C++
Python
MATLAB
Software Defined Radio (SDR)
AI/ML
Cybersecurity
RF Receiver Technology
Top Secret/SCI Clearance

Planner

Engineering
 New Jersey
$24.00-$28.00 HR
06 Months

Location : Florham Park NJ. Contract: 4 months with possible extension Schedule: On-Site M-F , 8-5 PM EST Job Duties: The Services Planner will schedule Field Service Technicians to ensure the goals and objectives of assigned service districts are accomplished on time, implemented at or below the estimated cost, and closed in a timely fashion. These activities include initiating, planning, scheduling, validating and ensuring work is complete to meet customer standards.

Planning
Technician
scheduling

Network Engineering

Engineering
 Massachusetts
03 Years

Location : Lexington MA. Responsible for building and maintaining the day today operation of computer networks that companies and organizations rely on. These networks typically include an intranet, extranet, local area network (LAN), and wide area network (WAN). Designs and plans network systems. Designing and developing the network for both LAN and WAN. Design, configure and deploy LAN and WAN network connections, hardware, software and communication links and services. Performing disaster recovery operations and data backups when required. Provides specifications and detailed schematics for network architecture. Provides specific, detailed information for technology selection, implementation, and deployment, and tools for the most efficient solution to meet business needs, including present and future capacity requirements. Conducts testing of network systems. Maintains technical expertise in all areas of network and computer hardware and software interconnection and interfacing, such as routers, switches, firewalls, proxies, load balancing, etc. Prepares appropriate network documentation, including operational instructions. Evaluates and reports on new network technologies, to enhance capabilities of the network. May require knowledge of network topography for cloud integration. May implement applications of machine to machine (M2M) communication to enhance the efficiency and security of the organization s operations. Group conducts systems analysis on a broad range of problems related to surface surveillance, force protection, and homeland defense. Activities include sensor and system modeling, mission requirements analysis, and architecture development. A variety of technologies are examined, including radar, optical, acoustic, biological, and chemical sensors. Modeling and the analysis of field measurements are used to quantify the ability of current and proposed technology to meet mission requirements. This work includes analysis, algorithm development, an

UDP
Networking

Customer Care Coordinator I

Engineering
 Illinois
06 Months

Location : Elgin IL. 1-2 years of experience working with customers and coordinating and scheduling customer events The HM does not want to see candidates that are overqualified with more than 4 years of experience, no one with a master's degree, no one with only call center/over the phone customer support experience. This is a customer facing role so should have good communication skills and professional appearance. This is a long term assignment therefore the HM is looking for someone with stable work history. HM can only interview with the morning. Please submit your candidate with availability to interview for the week. A fast-paced and dynamic environment, manufacturing world-class communications equipment and mission-critical solutions for first responders and public safety customers around the world. Job Description Experience: Prior experience in a direct customer interfacing role is required.

Spanish
Customer Care

Quality Engineer

Engineering
 Ohio
03 Months

Location - Fairfield, OH. We are seeking a Manufacturing Quality Engineer with 3+ years of experience in quality control, problem-solving (8D, FMEA, 5Why), and continuous improvement within a production environment, preferably with Six Sigma and ESD knowledge.

Quality
8D and FMEA
logo

At SGS Consulting, we go beyond resume-job matches, creating meaningful connections and pathways for individuals to thrive in defining careers.


2025. All right reserved.
logologologologo