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Control engineer Jobs in Boston, MA

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Control engineer • boston ma

Last updated: 1 day ago

Quality Control Manager

VertexBoston, MA
Full-time

The Quality Control Manager will be responsible for supporting the establishment and oversight of a new QC centralized external contract lab and management of other existing contract testing labs.T... Show more

Pest Control Service Professional

Clancy Brothers Pest ControlQuincy, Massachusetts, United States
Full-time
Quick Apply

Pest Management Professional (PMP) ($45k-$65k) $22-$30/hr.Do you enjoy problem-solving, working independently, and providing excellent customer service? As a Pest Management Professional with Clanc... Show more

Senior Electrical/Control Systems Engineer

Ingman CompanyBoston, MA, USA
Full-time +1

Our client is an engineering consulting firm focused on transit and rail projects across the US.This company has seen annual growth of almost 25% per year.BS in Electrical Engineer; MS a plus.Motor... Show more

Pest Control Technician

Yankee Pest ControlMalden, Massachusetts, United States
Full-time
Quick Apply

Join the Team at Yankee Pest Control!.Yankee Pest Control is a trusted, locally owned company serving residential and commercial clients.We’re looking for a reliable, motivated.This is a great oppo... Show more

Projects Control Accountant

0100 Mass General Brigham IncorporatedMA,Boston
Full-time

Site: Mass General Brigham Incorporated.Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to ... Show more

Sales Engineer- Motion Control

Steele StaffingBoston, MA
Permanent

Sales Engineer – Motion Control .A globally recognized motion control leader is seeking a Sales Engineer to drive growth across the New England region.This role is ideal for technically adept profe... Show more

Pest Control Technician

MOSQUITO SQUAD PLUS OF NEWTONNewton, MA, US
Full-time

WORK OUTDOORS - RUN YOUR OWN ROUTE!.Fast-growing mosquito & pest control company.Work outside independently and earn consistent pay.Steady hours + growth opportunities .Treat properties for mos... Show more

Application Solution Engineer, Servo Motor & Motion Control | Mandarin Preferred

Shanghai BSF Human Resources Co., LtdBoston, Massachusetts, United States
Remote
Full-time
Quick Apply

We are currently partnering with a leading industrial automation enterprise to recruit a full-time, US-based Application Solution Engineer focused on servo motor and motion control core systems.Thi... Show more

Licensed Control Electrician

INELLO ELECTRIC LLCREVERE, MA, US
Full-time

Guaranteed increase from current salary .You will be responsible for installing and repairing wiring, electrical fixtures, and control equipment, as well as training apprentices on the job.If you a... Show more

Pest Control Technician

General Environmental ServicesBoston, MA, US
Full-time

MUST HAVE A CURRENT MASSACHUSETTS PEST APPLICATOR LICENSE.Career Advancement Opportunities.In this role, you will inspect residential and commercial buildings for signs of pest infestation, advise ... Show more

Inventory Control Clerk

2810 Brigham and Women's Faulkner Hospital, Inc.MA,Jamaica Plain
Full-time

Site: Brigham and Women's Faulkner Hospital, Inc.Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems ana... Show more

Water Quality Control Operator

City of MedfordMedford, Massachusetts, United States
Full-time
Quick Apply

The position is responsible for performing skilled work on construction and maintenance projects while also keeping detailed records, collecting samples, gathering field data and utilizing asset ma... Show more

Control Engineer

AutomationtechiesBoston, MA, United States
Full-time

With over 40 successful years in business and having over 35 facilities across the USA, this engineering firm has been named on the ENR Top 500 Design Firm list and has continued to climb in rank o... Show more

Mosquito Control Technician

Mosquito JoeSaugus, MA, US
Temporary

This role is based out of our Wakefield, MA office.You must be able to report to this location to start and end your workday.You have options when it comes to finding a new career.When you put on a... Show more

Pest Control Technician

Buono Pest ControlBelmont, MA, USA
Full-time +1
Quick Apply

Are you ready to embark on an adventure that not only eliminates pests but also creates pest-free environments that our clients love? If you have a passion for solving problems, providing top-notch... Show more

Traffic Control Technician

Lane Valente IndustriesBoston, MA, US
Full-time
Quick Apply

Lane Valente Industries is a Leading International construction and facility maintenance company with offices throughout the U.We have a strong in-house group of field technicians that services top... Show more

Sr. Software Engineer - Amazon FSx, FSx Control Plane

Amazon Web Services, Inc.Boston, Massachusetts, USA
Full-time

Do you want to join a team of creative and talented software engineers who are building and operating world class services built on amazing open source technology? The Amazon FSx Control Plane engi... Show more

Document Control Coordinator

Navstar Inc.Cambridge, MA, United States
Full-time

Overview: Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA.The 2,000+ employees of Draper tackle important national challenges with a promise of d... Show more

Projects Control Accountant

Massachusetts General HospitalBoston, MA, United States
Full-time

Mass General Brigham Financial Analyst.Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to a... Show more

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Quality Control Manager

Quality Control Manager

VertexBoston, MA
30+ days ago
Job type
  • Full-time
Job description

Job Description

General Summary:

The Quality Control Manager will be responsible for supporting the establishment and oversight of a new QC centralized external contract lab and management of other existing contract testing labs. The position will manage GMP release and stability activities in support of clinical and commercial biologics programs while ensuring compliance with SOP’s, policies, and industry guidance. In addition, this role will help support the transfers/validation of GMP analytical methods, participating in establishment and implementation of internal Quality Control systems, processes and procedures in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations. This role will interact with internal cross-functional teams and our network of external CMOs/contract labs to ensure that all GMP analytical methods for lot release and stability testing of drug substance and drug product biologics are implemented successfully.

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid: work remotely up to two days per week; or select

On-Site: work five days per week on-site with ad hoc flexibility

Key Duties and Responsibilities:

  • Supporting QC activities for early to late-stage clinical/commercial biologics programs.
  • Supporting the establishment and oversight of a new QC external centralized contract lab, managing QC activities/programs such as release, stability, reference standard, method validation/transfer, method lifecycle management, specifications, spec settings, sampling plans, deviations, OOS/OOT investigations, root cause analyses, CAPAs.
  • Manage relationship with contract testing lab; help set and monitor business and quality KPIs and drive continuous improvement projects.
  • Manage and provide CDMO oversight on placebo, Drug Substance and Drug Product QC activities.
  • Ensure all activities are completed according to timelines and quality standards.
  • Perform document review, study design, sample management, data review, risk assessment and trending analysis.
  • Plan, manage, and communicate stability pull dates and ensure stability testing occurs within specified testing windows. Establish/extend DS and DP shelf lives with internal stakeholders to ensure uninterrupted clinical supplies.
  • Manage reference standard inventory and support qualification testing activities,.
  • Ensure method validation and transfer activities are performed in accordance with ICH/EMA/USP/Ph. Eur. Guidelin6es.
  • Manage cell bank, DS, DP, and placebo release and stability GMP specifications including justification of specifications and specification revisions.
  • Perform QC impact assessments on product temperature excursions occurred at clinical sites and storage depots.
  • Support processes related to QC systems and procedures. Proactively manage QC gap analyses and SOP revisions for continuous improvement.
  • Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine’s/Vertex network of external CMOs/contract labs to support company’s clinical programs.
  • Help support pre-licensure inspection and on-goings at CMOs/contract labs.

Knowledge and Skills:

  • Strong knowledge of QC principles, concepts, industry practices, and standards.
  • Experience in characterization, method development, validation, and transfer of non-compendial and compendial analytical methods for biologics using various techniques such as HPLC, CE, icIEF, and mass spectrometry (MS), as well as biophysical characterization methods.
  • Extensive knowledge of cGMP regulations and guidelines.
  • Demonstrated experience and independence with QC functions associated with the GMP production and testing of biologics in clinical and/or commercial settings.
  • Demonstrated ability to work effectively to timelines in a virtual environment (i.e., internal partners, external CROs, CMOs, CTLs, etc.) and manage QC deliverables.
  • Experience contributing to product quality risk assessments to identify critical quality attributes and developing associated limits/specifications.
  • Excellent written and verbal communication skills.
  • Comfortable in a fast-paced company environment and able to prioritize and adjust workload based upon changing priorities.
  • Travel Requirements: Travel to main office and CDMOs required (20% as required).

Education and Experience:

  • B.S. or M.S. degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with 6 + years industry experience in analytical development and/or quality control in a pharmaceutical setting.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.