Quality Assurance Associate

SGS_JOB_3182

Scientific
 North Carolina
Validation
Qualification
Review and approve

Contract - 12 Months

Location : Sanford, NC. 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.
  • Author, review and approved controlled documents for the Quality organization including SOPs, specifications, protocols, and reports.

Skills:

  • Validation, Qualification, Review and approve

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 biologic manufacturing facilityExperience 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
  • Off hours coverage and flexibility may be required.

Related Jobs

Lab Technician I

Scientific
 Illinois
6 months

Location: Rockford, IL 61103 Performs a variety of laboratory tasks under the supervision of a Scientist/Researcher. The technician will use both standard procedures and adapted processes to support specific projects and routine operations, while collaborating with maintenance staff to ensure smooth equipment functioning.

Test Schedule
Supervision
Laboratory Work

Contract Membership Specialist

Scientific
Remote
12 Months (possible extension)

M-F, 8am - 5pm. Full time, No OT... 100% Remote, Needed for at least one year, high possibility to extend for the full two years, No specific area/degree but must have a Bachelors Degree minimum... Candidate must be willing to participate/lead meetings and team calls occasionally. Manager values a candidate that is highly driven to learn to skills and take on new projects voluntarily. Manager likes candidates that are inquisitive. Need someone who is HIGHLY analytical. They'll be searching various systems, if they see something wrong they'll need to "go down the rabbit hole" to find out "why?" Need strong critical thinking skills to know when to search system to system for various bits of info. Must have experience working with multiple large data management systems, contracts and pricing, and/or contract development and analytics. Must have very strong writing/grammar and communication skills. Needs to have high attention to detail and accuracy. Interviews will be one with manager and then a panel interview. Must be able to perform high level Excel functions, formulas, vlook-ups. BONUS - manager would like to see Excel test scores. Resolve membership affiliation and inquiries from account management teams. Monitor Revenue Manager platform and boundary systems to confirm data accuracy. Responsibility for managing daily business tasks and processes with internal/external key stakeholders. Access and process data within reporting tools, including Revenue Manager, MicroStrategy, and boundary systems. Communicate and resolve membership discrepancies with internal and external customers; resolve inquires, maintain synchronization and integrity of membership. Create, maintain, and support a collaborative environment with external customers and internal business partners. Responsible and accountable for data compliance activities within membership and the oversight and execution of applicable processes and business decisions to achieve compliance. Ensure accurate and up-

Model N
SAP
SAP-ishift
Contracting
Pricing
Membership

Laboratory Assistant

Scientific
 California
$18-$19
3 months

Location (mandatory): San diego CA Looking for a lab technician with some laboratory experience

sampling
lab equipment
SOP
Labware

Manufacturing Services Associate I

Scientific
 New Hampshire
12 months

Location (mandatory): Portsmouth NH The Manufacturing Services Associate I is responsible for supporting all cGMP manufacturing production suites. They support the production groups by ensuring the suites are appropriately stocked with raw materials and consumables, assemble and autoclave assemblies for use, clean soiled parts, perform daily/weekly maintenance on analytical equipment, and complete scheduled cleaning requirements that are not fulfilled by Lonza’s contracted cleaning staff. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique and cross contamination awareness in handling of products and materials. 1-3 Yrs Experience

Manufacturing experience GMP aseptic technique

Scientist II

Scientific
 California
$57/hr (Negotiable)
10 Months + (Possibilities of Contract Extension)

Location : San Diego CA USA 92121 We are seeking a motivated and detail-oriented Scientist II (Senior Scientist equivalent) for a one-year temporary assignment within our R&D Assay Development On-Market Support team..

IVD Molecular Diagnostic Assay Product Development
Assay Development
R&D

Validation Engineer II

Scientific
 California
$37.38- $62.29 /hr on w2
05 Months

Location : Vacaville California With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Genentech corporate principals, quality policies, standards and core values. Maintains company’s right to operate, supply to patients, and cost effectiveness by actively participating in continuous improvement projects.

Validation
GMP
Equipment.

DIGITIVA Coach

Scientific
Remote
12 Months

As DIGITIVA Coach, you’ll partner with individuals enrolled in the DIGITIVA™ heart failure management program to support behavior change, engagement, and sustained habit formation. You’ll use digital tools (e.g., messaging, phone, video) to deliver coaching, monitor progress, and deliver program-specific outreach to DIGITIVA users post-hospital discharge and when adherence or outcomes lag. You’ll also collaborate with cross-functional teams (operations, medical affairs, clinical, product) to refine coaching protocols and improve user experience.

Health Coaching
Chronic Disease

Biotechnologist Associate

Scientific
 New Hampshire
12 Months

Location : Portsmouth NH. Looking for a candidate with science degree and some manufacturing experience

GMP
cGMP
lab work

Composite Technician

Scientific
 California
$30 - $33
12 Months (possible extension)

Location (mandatory): Carlsbad, CA 92008. We are seeking an experienced Composite Technician to join our team. The ideal candidate will be a U.S. citizen with at least 5 years of hands-on experience in composite manufacturing processes such as prepregs, wet layup, and vacuum resin infusion. The role requires strong technical skills, including the ability to read blueprints, use precision measuring tools, and follow aerospace/defense quality standards like AS9100 and NADCAP. Candidates should be detail-oriented, physically capable of handling up to 50 lbs., and possess strong communication and teamwork skills. Experience with autoclave curing, composite repair, and process improvement (Six Sigma preferred) is highly desirable. Role Definition: The Carlsbad, CA site is looking for a skilled Composites Technician to join our advanced manufacturing team. The successful candidate will be responsible for fabricating, assembling, and repairing composite components. This role requires precision, attention to detail, and the ability to follow strict process controls in support of aerospace, defense, and high-performance product manufacturing.

Composite manufacturing (Prepregs
Wet Layup
Vacuum Resin Infusion)
Blueprint and technical drawing interpretation
Aerospace and defense quality standards (AS9100
NADCAP)
Composite repair technique
Autoclave and oven cure process knowledge
Precision measuring tools (calipers
micrometers
gauges)
Process improvement (Six Sigma Green/Black Belt preferred)
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