Quality Control Scientist

SGS_JOB_3858

Scientific
 Massachusetts
Senior Manager
Quality Control Raw Materials

Contract - 12 Months + (highest possibilities of contract extension)

Location- Westborough, MA 01581. The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead. This role will mentor junior analysts and develop and facilitate training initiatives within the labs. Preferred: • Experience in a Biotech/Pharmaceutical company with a high growth, fast-paced environment. • Experience in qualification of analytical equipment, including those with computerized systems. • Experience in method validation/qualification/verification/transfer. Working Conditions: • This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs. • This is an on-site role working in a cGMP regulated manufacturing facility.

Job Responsibilities:

  • Develop/author/revise technical reports and laboratory procedures (SOPs, methods).
  • Execute and troubleshoot raw material testing in support of production activities.
  • Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures.
  • Design and perform testing in support of method transfer/validation/qualification/verification.
  • Review/authorize data and perform analysis and interpretation of test results and trends.
  • Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations.
  • Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration.
  • Support and mentor junior team members.
  • Collaborate with other network sites to share best practices.
  • Other duties as required.

Skills:

  • The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality.
  • The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials.  This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Client Gene Therapies and the Client organization

Education/Experience:

  • B.S. degree in chemistry, biological sciences or related field with 6+ years or M.S. degree with 4+ years of relevant experience in a GMP Quality Control role.
  • Prior laboratory hands-on experience with a variety of techniques such as FTIR, Raman, Near-IR, HPLC analysis and other compendial assays.
  • Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing.
  • Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements).
  • Ensures inspection, testing and release timelines are met.
  • Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries and proven experience analyzing experimental data.
  • Experience using LIMS as an end user; Excellent technical writing and verbal communication skills.
  • Must be capable of observing and adhering to lab safety standards and procedures.
  • Successfully performs work independently with minimal instructions.
  • Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment, strong knowledge of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements.
  • Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion.
  • Highly self-motivated and goal oriented.
  • Will support and demonstrate quality standards to ensure data of highest quality and works closely with team and other functional key stakeholders on the Client Operations team to execute work and will be expected to perform other duties and/or special projects as assigned.

Related Jobs

Lab technician

Scientific
 Massachusetts
02 years + (Highest possibilities of contract extension)

Location: Cambridge, MA 02139 Description: The primary role of the Media Prep Technician is to prepare pharmaceutical buffers, agar plates, and tissue culture media for Client’s lab operations in Cambridge, MA. Formulating buffers, plates and media for the PRD community allows our scientists to focus their time and skills on developing Breakthroughs That Change Patients’ Lives

Data extrapolation
Biopharma

QA Specialist II

Scientific
 Texas
6 Months

A QA Specialist II (Quality Operations) ensures that manufacturing and related processes comply with regulatory and quality standards such as GMP and ISO. The role involves supporting production activities, reviewing documentation, overseeing compliance, and contributing to continuous improvement in a biopharmaceutical or life sciences environment.

Quality
Capa
Gmp

CMC Regulation – Manager

Scientific
Remote
06 Months + (highest possibilities of contract extension)

This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific projects working as or working with the Regulatory CMC Lead and key stakeholders, primary contact for affiliates on Regulatory CMC activities in the assigned regions and managing of routine and non-routine Health Authority interactions as delegated. Depending on the stage of development and complexity of the program, this role can be a Regulatory CMC Lead for early stage development programs or working with the Regulatory CMC Lead for late stage development or commercial programs. The Regulatory CMC Lead is the primary global contact for Regulatory CMC activities, as delegated. This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, Regulatory CMC knowledge and interpersonal skills are required. 100% Remote or hybrid (Cambridge, MA or RTP)

Strong conflict resolution skills
GMP
CMC

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

USA - Quality Control Testing Technician - I - USD

Scientific
 Massachusetts
12 months Contract

This position for employment is in the Andover Quality Control Microbiology Laboratory working first shift supporting Laboratory operations Monday through Friday with occasional weekend and holiday coverage. The candidate should be flexible to support both assays performed in the Laboratory, as well as office-based work as needed to support the business. Non-Standard Work Schedule, Travel Or Environment Requirements Some rotational weekend and Holiday coverage is required to support the commercial manufacturing schedule. Adhere to safe work practices and procedures, including aseptic gowning procedures

Quality Control
Testing
Technician

QC Microbiology, Analyst I

Scientific
 Massachusetts
06 Months + (highest possibilities of contract extension)

Location: - Westborough, MA 01581 (On-site) The primary purpose of the Analyst I position is to Support Quality Control Microbiological testing of drug substances, raw materials and process intermediates in support of clinical development and commercial programs under cGMP and GLP guidelines, address excursions and conduct investigations.

lab testing data
logbooks
QC analysis

QC Specialist II

Scientific
 New Hampshire
12 months

Location (mandatory): Portsmouth NH USA 03801 Small Description: The QC Specialist II will join the Quality Control department and assist with technical transfer activities, contributing to the testing and analysis of in-process samples, final product testing, and stability studies. This role requires familiarity with GMP (Good Manufacturing Practices) systems, quality records, and testing methodologies. The individual will work collaboratively to complete complex tasks while ensuring adherence to industry regulations, contributing to method transfers, instrument qualifications, and validation activities.

QC
Capa
investigation

Food Product Manager/Food Product Evaluator II

Scientific
 California
$45 - $46
06 Months (possible extension)

Location (mandatory): Pleasanton, CA 94588 The Product Manager / Product Evaluator II supports food product development by managing product samples, documentation, testing, and evaluations across multiple categories. This role plays a key part in new product demonstrations, sensory evaluations, and finished product specifications while ensuring food safety, quality, and accurate reporting—enabling product development teams to focus on strategic initiatives.

Food Product Development & Evaluation
New Product Development (NPD) Support
Food Sample Management & Inventory Control
Sensory / Organoleptic Evaluation
Product Testing (pH
Viscosity
Texture Analysis)
Food Safety
Microbiology & GMP Practices
Finished Product Specifications & Documentation

Scientist I (Scientific)

Scientific
 Massachusetts
12 months

Location:- Cambridge, MA 02141 (Onsite) Work Schedule: Generally, Monday to Friday 08 Am to 05 Pm EST (slight flexibility in hours) potential weekends (max 40 hrs)

study design
data collection
logo

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


© 2026 All rights reserved.
logologologologo