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Quality Control ScientistII || Framingham, MA || Type-6-month Contract ||$38-40/hr

ashishsisodiya45 August 1, 2020
Job Role- QC Scientist II

Employment Type-6-month contract
Pay rate-$38-40/hr
Location-Framingham,MA

Position Summary


Quality Control Validation Scientist I is responsible for the qualification activities, following SOPs and regulations including Data Integrity, related to one or more of the following areas: IQ, OQ, PQ and requalificatio

Core Responsibilities
• Perform qualification in a cGMP biotech facility managing multiple complex qualification projects and providing technical assistance to less experienced team members.
• Write, review and approve qualification protocols and reports as well as execute protocol. Resolve protocol discrepancies and deviations.
• Evaluates new technologies platforms for implementation in the QC Laboratories.
• Ensure GMP compliance of all activities performed.
• Represent QC Validation in internal and external audits as required.
• Ensure appropriate facility support and provide technical expertise with regards to equipment.
• Review standard operating procedures.
• Maintain positive relationship and network effectively across sites and organizations.
• Provide project oversight and participate in cross-functional teams.
• Practice safe work habits and adhere to Genzyme’s safety procedures and guidelines. An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
• Perform other additional job related duties as required.
• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Skills:

• Knowledge of Validation Lifecycle Approach.
• Knowledge of Validation Data Integrity Principals
• Ability to present technical data.
• Ability to work independently on scientific projects.
• Scientific technical writing ability authoring and reviewing SOPs, qualification protocols and technical reports.
• Experience troubleshooting of assay and equipment issues

Education:

• Bachelor’s degree in Life Sciences discipline and 5 years of experience in cGMP lab environment, or
• Master’s degree in Life Sciences discipline and 3 years’ experience in cGMP lab environment.
• PhD in Life Sciences discipline and 0-3 years’ experience in cGMP lab environment

 

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Research Associate-II || Waltham, MA || Type-2-Year Contract ||$40-45/hr

ashishsisodiya45 August 1, 2020
Job Role- Research Associate II

Employment Type-2-year contract
Pay rate-$40-45/hr
Location-Waltham,MA

Job Specific Duties:

Perform formulation screening, prepare and characterize dosing formulations for animal studies. Conduct HPLC method development and samples analysis of small molecules in support of discovery formulation development. Measure protein concentration of monoclonal antibodies to support biotherapeutic programs. Troubleshoot analytical instrumentation and solve technical problems. Independently conduct formulation research and process improvement as needed. Interpret results and write technical reports. Responsible for general laboratory maintenance, buffer preparations, labeling, packaging and shipping of outgoing materials.

Skills:

HPLC, SEC, UV and LC/MS
Microscopy
Particle size analysis
Experience with solubility, stability studies and formulation screening.
Ability to multi-task and work efficiently in a fast paced and dynamic environment.
Ability to manage multiple projects while maintaining efficiency and effectiveness.
Ability to independently design experiments and conduct formulation research.
Excellent organizational and communication skills.
Ability to work independently and in a team environment.

Education:

MS (with 0-5 years related experience) in pharmaceutical sciences or analytical chemistry.

General Duties:

Responsible for the execution and analysis of experiments and analytical procedures. Display an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures. Investigate basic technical problems and performs routine scientific procedures and experiments under general supervision. Plan and prioritize concurrent experimental procedures. Integrate, compile, and tabulate data and assist supervisor in the analysis and interpretation of the results. May provide oral presentations on results to other department members. Contribute to the completion of milestones associated with specific projects. Frequent internal company contacts. Infrequent inter- departmental and outside constituent contacts on routine matters. 

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Compliance Specialist III || Framingham, MA || Type-2 Year Contract ||$35-40/hr

ashishsisodiya45 July 30, 2020

Compliance Specialist III

Location: Framingham, MA

Pay Rate: $35-40 per hour

Responsibilities

  • Perform audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation. Establish auditing requirements, quality standards and test methods in accordance with regulations and relevant quality requirements. Conduct internal audits of manufacturing processes to ensure compliance. Conduct review of testing results. Review document and complete inspection of returned goods. May be involved with establishing compliance requirements for the methodology transfer from Research to Quality Control. Interpret complex, explicit documentation to ensure quality standards and compliance. May provide training to new employees. Work under only very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy. Contribute to the completion of organizational projects and goals. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify. Frequent internal company and external contacts. Represent organization on specific projects. 

Qualifications

    • BS/BA degree in a Scientific/Manufacturing/Quality Assurance discipline.
    • Years of Experience: 6 – 9 Years

Skills-SOP, Quality Assurance, CAPA, GMP (Good Manufacturing Practice)

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Seniority Level

Associate level

Industry
  • Staffing & Recruiting  
  • Biotechnology  
  • Pharmaceuticals
Employment Type

2-year Contract

Job Functions
  • Quality Assurance
  • Documentation

QA Documentation || Framingham, MA || Type-6-month Contract ||$25/hr

ashishsisodiya45 July 28, 2020

QA Documentation

Location: Framingham, MA

Pay Rate: $25 per hour

Responsibilities

  • Track and review change control documentation. Assist with the editing of quality documents (Master Batch Records, SOPs, guidelines, etc.) to ensure compliance with regulator and internal quality requirements. Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, be able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. Prepare and/or maintain documentation pertaining to programming, systems operation, and user documentation. Translate business specifications into user documentation. Plan, write, and maintain systems and user support documentation efforts; including online help screens. Knowledgeable of commonly used concepts, practices, and procedures within a particular field. Rely on instructions and pre-established guidelines to perform the functions of the job

Qualifications

    • Bachelor’s degree in Life Science
    • 0-2 years of QA Documentation experience.
Apply here
Seniority Level

Entry level

Industry
  • Staffing & Recruiting  
  • Biotechnology  
  • Pharmaceuticals
Employment Type

Contract

Job Functions
  • Quality Assurance
  • Documentation

Lab Technician-II || Swiftwater, PA || Type-6-month Contract ||$35-40/hr

ashishsisodiya45 July 28, 2020

Laboratory Technician II

Location: Swiftwater, PA

Pay Rate: $35-$40 per hour

Responsibilities

  • Execution of small scale experiments and working with eggs and with flu virus concentrate material.
  • Running hemagglutination testing, optical density testing, process (TFF and sterile) filtration and process centrifugation.
  • Ordering and maintaining supplies and materials and shipping materials as needed
  • Sample management.
  • 5S and lab maintenance.
  • Flexibility to work off-shift and weekends as needed.
  • Focus on site safety.

Qualifications

    • Bachelor’s degree required in biology or related Life Science
    • 2+ years of laboratory experience.
    • Work in a fast paced team environment requiring multitasking ability
    • Interpersonal skills
    • Communication skills
    • Teamwork skills
    • Organizational skills
    • Must be detail oriented

Preferred Skills

  • Preferred vaccine production experience including tangential flow filtration, centrifugation and aseptic technique.

 

Apply here
Seniority Level

Entry level

Industry
  • Staffing & Recruiting  
  • Biotechnology  
  • Pharmaceuticals

 

Employment Type

Contract

Job Functions
  • Research  
  • Analyst  
  • Information Technology