Quality Assurance Engineer

3 weeks ago

Framingham, United States DPS Group LLC Full time

Summary

DPS Engineering is looking for a Quality Assurance Specialist .The candidate will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in clinical and/or commercial products. This individual will work closely with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Digital and Manufacturing Science and Technology counterparts.

Key ResponsibilitiesOversee and review executed electronic and paper batch record documentation.Author and review SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.Closely partner with peers for rapid review of batch-related documentation.Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.Monitor process operations to ensure compliance with specifications.Assist in the investigation of procedural deviations.Oversees execution of CAPAs, deviations and change controls in support of PCV manufacturing.Reviews minor manufacturing deviations.Develop batch records, SOPs and training materials as needed.Demonstrate a general knowledge of standard manufacturing compliance, quality disposition, quality system review.Utilize knowledge to improve operational efficiency.Participate in quality oversight of manufacturing through real-time observations of activities.Skills & Qualifications

At least 5 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor's Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLPAbility to collaborate fluidly with peers, supervisors and cross-functional support groups requiredExceptional written, oral communication, and organizational skills requiredMust be able to work under general direction to plan, coordinate, and ensure completion of engineering team deliverables.Effective verbal and written communication skills.Excellent interpersonal, teamwork, and leadership skills required.Participates in determining objectives of assignment and plans, schedules and arranges own activities in accomplishing milestone achievements.

The Company

DPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a 'client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.

DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.

#LI-NH1 #J-18808-Ljbffr

  • Director, Quality Assurance

    2 weeks ago

    Framingham, Massachusetts, United States Michael Page Full time

    About Our Client Our client specializes in providing healthcare professionals with advanced tools that enhance precision and control in treating complex medical conditions. They are dedicated to the science of innovative treatment technologies, focusing on creating durable and effective solutions. Their mission is to deliver exceptional patient care through...

  • Director, Quality Assurance

    2 weeks ago

    Framingham, Massachusetts, United States Michael Page Full time

    About Our Client Our client specializes in providing healthcare professionals with advanced tools that enhance precision and control in treating complex medical conditions. They are dedicated to the science of innovative treatment technologies, focusing on creating durable and effective solutions. Their mission is to deliver exceptional patient care through...

  • Quality Engineer

    1 month ago

    Framingham, United States Sofregen Inc. Full time

    Sofregen Medical is an emerging medical device company founded in 2014. Sofregen Medical is focused on leveraging the silk protein as a biomaterial for medical applications. Our mission is to provide our patients with a fresh start, restore confidence, and improve their quality of life. Please visit our website at www.sofregenmedical.com for more details on...

  • Quality Engineer

    4 weeks ago

    Framingham, United States Sofregen Inc. Full time

    Sofregen Medical is an emerging medical device company founded in 2014. Sofregen Medical is focused on leveraging the silk protein as a biomaterial for medical applications. Our mission is to provide our patients with a fresh start, restore confidence, and improve their quality of life. Please visit our website at www.sofregenmedical.com for more details on...

  • Quality Engineer

    4 weeks ago

    Framingham, United States Sofregen Inc. Full time

    Sofregen Medical is an emerging medical device company founded in 2014. Sofregen Medical is focused on leveraging the silk protein as a biomaterial for medical applications. Our mission is to provide our patients with a fresh start, restore confidence, and improve their quality of life. Please visit our website at www.sofregenmedical.com for more details on...

  • Quality Engineer

    1 day ago

    Framingham, United States Sofregen Inc. Full time

    Sofregen Medical is an emerging medical device company founded in 2014. Sofregen Medical is focused on leveraging the silk protein as a biomaterial for medical applications. Our mission is to provide our patients with a fresh start, restore confidence, and improve their quality of life. Please visit our website at www.sofregenmedical.com for more details on...

  • Director, Quality Assurance

    2 weeks ago

    Framingham, United States Michael Page Full time

    About Our Client Our client specializes in providing healthcare professionals with advanced tools that enhance precision and control in treating complex medical conditions. They are dedicated to the science of innovative treatment technologies, focusing on creating durable and effective solutions. Their mission is to deliver exceptional patient care through...

  • Director, Quality Assurance

    2 weeks ago

    Framingham, United States Michael Page Full time

    About Our Client Our client specializes in providing healthcare professionals with advanced tools that enhance precision and control in treating complex medical conditions. They are dedicated to the science of innovative treatment technologies, focusing on creating durable and effective solutions. Their mission is to deliver exceptional patient care through...

  • Quality Engineer III

    3 weeks ago

    Framingham, Massachusetts, United States Staples Full time

    Quality Engineer III Work Model; Hybrid, Framingham, MA Staples is business to business. You're what binds us together. Our digital solutions team is more than a traditional IT organization. We are a team of passionate, collaborative, agile, inventive, customer-centric, results-oriented problem solvers. We are intellectually curious, love advancements in...

  • Quality Engineer III

    2 weeks ago

    Framingham, Massachusetts, United States Staples Full time

    Quality Engineer III Work Model; Hybrid, Framingham, MA Staples is business to business. You're what binds us together. Our digital solutions team is more than a traditional IT organization. We are a team of passionate, collaborative, agile, inventive, customer-centric, results-oriented problem solvers. We are intellectually curious, love advancements in...

  • Senior Associate, Plant Quality Assurance

    2 weeks ago

    Framingham, United States Replimune, Inc. Full time

    OverviewSummary of job description: This Senior Associate PQA position is the primary QA resource during manufacturing production activities, providing real time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities. This position will be required to proactively support cGMP compliance and interact with all...

  • Senior Associate, Plant Quality Assurance

    2 weeks ago

    Framingham, United States Replimune, Inc. Full time

    OverviewSummary of job description: This Senior Associate PQA position is the primary QA resource during manufacturing production activities, providing real time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities. This position will be required to proactively support cGMP compliance and interact with all...

  • Senior Associate, Plant Quality Assurance

    1 week ago

    Framingham, United States Replimune, Inc. Full time

    Overview This Senior Associate PQA position is the primary QA resource during manufacturing production activities, providing real time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities. This position will be required to proactively support cGMP compliance and interact with all departments within the...

  • Senior Associate, Plant Quality Assurance

    4 days ago

    Framingham, United States Replimune, Inc. Full time

    Overview This Senior Associate PQA position is the primary QA resource during manufacturing production activities, providing real time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities. This position will be required to proactively support cGMP compliance and interact with all departments within the...

  • Process Engineer II

    2 months ago

    Framingham, United States CareerBuilder Full time

    Description We're looking for a Process Engineer II , working in Pharmaceuticals and Medical Products industry in 76 New York Avenue, Framingham, Massachusetts, 01701, United States . Job description: Execute concurrent projects of moderate scope and complexity, with minimal supervision. Interpret and execute policies and procedures. Recommend modifications...

  • Mechanical Design Engineer

    1 month ago

    Framingham, United States The Fountain Group Full time

    Onsite PositionDescription: Develop process design basis, including sizing and selection of equipment, mass balance, URS and instrumentation for control of robust processes. Provide input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections, and...

  • Mechanical Design Engineer

    4 weeks ago

    Framingham, United States The Fountain Group Full time

    Onsite Position Description: Develop process design basis, including sizing and selection of equipment, mass balance, URS and instrumentation for control of robust processes. Provide input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections,...

  • Lead Electrical Engineer

    4 weeks ago

    Framingham, United States DPS Group Global Full time

    Position Summary: The Lead Electrical Engineer manages electrical engineering activities within the organization. Implements and maintains policies and procedures for designing, performing calculations and details for installing electrical systems. Responsible for reviewing and approving new or revised designs, or installation procedures. Ensures engineering...

  • Process Engineer II

    3 weeks ago

    Framingham, United States PSG Global Solutions Careers Full time

    Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Process Engineer II, working in Pharmaceuticals and Medical Products industry in 76 New York Avenue, Framingham, Massachusetts, 01701, United States. Job description:Execute concurrent projects of moderate scope and...

  • Lead Electrical Engineer

    4 weeks ago

    Framingham, United States DPS Group Global Full time

    Position Summary:The Lead Electrical Engineer manages electrical engineering activities within the organization. Implements and maintains policies and procedures for designing, performing calculations and details for installing electrical systems. Responsible for reviewing and approving new or revised designs, or installation procedures. Ensures engineering...