Compliance Specialist CMC, Quality Assurance

SGS_JOB_2862

Scientific
 Massachusetts
Quality Assurance
Data review
QA review
GMP

Contract - 6 Months

Location : Westborough MA USA The Compliance Specialist will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory Submissions at AIRM. The successful candidate will foster data integrity, quality, and compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts at Astellas to help ensure high quality standards and value delivery for our patients. This position is based in Westborough, MA and will require on-site work.

Job Responsibilities:

  • Essential Duties and Responsibilities include, but are not limited to, the following:
  • Performs QA review of executed GMP analytical batch records; in-process, release, and stability data to ensure compliance with regulatory requirements, internal quality standards, internal procedures, and contribute to the overall Quality Assurance processes.
  • Performs QA review of executed development studies intended for regulatory submissions, included but not limited to, draft batch records, analytical test records, and calibration records to ensure Developmental studies are conducted and data collected in compliance with approved protocols, appropriate corporate guidelines, internal procedures, domestic and global regulatory guidelines and standards.
  • Identifies and reports documentation errors and deviations from test / data records, protocols, Standard Operating Procedures (SOPs), or specifications in a timely manner.
  • Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence.

Skills:

  • Quality Assurance
  • Data Review
  • QA Review
  • GMP

Education/Experience:

  • BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
  • Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).
  • Preferred Qualifications:
  • Demonstrated knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy and other international regulatory requirements.
  • Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles.

Related Jobs

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)

Operations Technical Associate I

Scientific
 California
$26-$30 /hr
06 Months

Location (mandatory): San Diego CA USA 92121 The Operations Technical Specialist 1 supports various areas of manufacturing including production and testing by, under guidance, executing tasks for resolution of technical challenges, business continuity or continuous improvement initiatives related to product or processes. Knowledge of cGMP, QSR and ISO regulated environments including knowledge of compliance enforcement necessary for 510K and PMA products.

Good Laboratory Practices
FDA cGMP
ISO13485
laboratory

Health Physics Planner III

Scientific
 Washington
03 Months

Location : Richland, WA 99352 Responsible for a variety of radiation protection functions, including plant problem analyses, licensing basis documents, implementation of large-scale radiation-protection-based projects, regulatory, EPRI and INPO interface or liaison assignments, instrumentation, dosimetry calculations, corrective action management, and performance improvement. Works independently and provides technical guidance and leadership within the assigned specialty.

Health Physics
Radiation

The Compliance Specialist CMC, Quality Assurance

Scientific
 Massachusetts
6 Months

Location (mandatory): Westborough MA USA The Research Associate role will provide a supporting role for ongoing research activities.

Quality Assurance
Data review
QA review
GMP

Sourcing Manager, Diagnostics Direct Procurement

Scientific
 Arizona
12 Months (possible extension)

Location (mandatory): Tucson, AZ • Primary Location: Tucson, AZ (split time between Marana site and Oro Valley site) • Mandatory to be on-site at least 3 days per week (Tuesday and Thursdays at Oro Valley Campus. Wednesday at Marana campus). Experience: • Experience or demonstrated understanding in supporting cost reduction and value improvement programs. • Experience in operational excellence or continuous improvement methodologies as well as experience in Life Sciences are a plus. • Experience with enterprise systems and procure-to-pay tools and eSourcing tools is desired.

Procurement
Contracting
Business Enterprise Systems
Spot Buying
Cost Reduction ERP

Accounts Receivable Administrative

Scientific
 Florida
03+ Months Extendable

Location : Weston, FL 33331 (Hybrid). The Accounts Receivable Clerk will be a temporary position to aid and assist the Collections Department with general duties including, but not limited to, phone calls, data entry, and administrative tasks.

AR
Account Receivable
Collection
Past Due
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