Tag: cGMP

QA Deviation || Norwood, MA || Type-6+ Months Contract ||$50-75/hr||On-site

ashishsisodiya45 June 7, 2021
Job Role- QA Deviation

Employment Type-6+month contract
Pay rate-$50-75/hr
Location-Norwood, MA

Here’s What You’ll Do:

  • Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.)

  • Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met

  • Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories

  • Review and approve validation protocols and reports to ensure compliance

  • Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans

  • Support disposition of DNA plasmid materials

  • Review stability protocols and reports

  • Collaborate with Manufacturing and lead investigation teams to resolve equipment and process related deviations

  • Communicate project requirements and issues to Quality Management

  • Conduct internal audits, track progress, and trend results

  • Participate in supplier audits

  • Support the collection of data/metrics for Management Review

  • Support Contract Manufacturing sites and perform Person-in-Plant duties as required

  • Review relevant sections of regulatory filings

  • Provide guidance on GMP manufacturing from Phase I to Commercial

 

Here’s What You’ll Bring to the Table:

  • BS with at least 3 years’ experience, or a Master’s level degree and 1-2 years’ experience in the pharmaceutical/biotech industry within Quality Assurance or Quality (Assurance) exposure

  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations.

  • Experience working with CMOs, vendors, and relationship management preferred.

  • Experience working with DNA plasmid materials manufacturing preferred.

  • Excellent judgment and ability to communicate complex issues in an understandable way.

  • Outstanding communication skills (verbal and written).

  • Auditing experience is a plus.

  • Familiarity with PDA Technical Reports 22, 26, 60, and 79 preferred.

  • Knowledge of late-stage pharmaceutical development and validation principles preferred

  • Ability to manage multiple projects in a fast-paced environment.

  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.

 

Apply here

Quality Control Analytical Associate II || Allendale, NJ || Direct Hire || Full-time

ashishsisodiya45 August 7, 2020
Job Role- Quality Control Analytical Associate II

Employment Type-Direct Hire/Full-time
Location-Allendale, NJ

Position Summary

Responsible for performing Quality control activities with minimal supervision of daily tasks in support of HCATS and client procedures. Procedures are expected to be performed with precision and accuracy and demonstrate a high level of documentation accuracy and clarity. Compliant with all applicable SOP’s and good documentation practices as well as cGMP and cGTP requirements. Identify problems that may adversely affect test performance or reporting of test results, correct the problems encountered or immediately notify your manager. Document all corrective actions taken when test systems deviate from the laboratories established performance specifications.

Core Responsibilities

  1. Perform the accurate execution of test methods and procedures. 
  2. Maintain inventory of QC materials and lab supplies, including monitoring and ordering 
  3. Perform maintenance, monitoring, and troubleshooting of pertinent equipment 
  4. Perform reagent and media preparation 
  5. Compliant with all applicable SOPs and good documentation practices(GDP) as well as cGMP/GCTP requirements 
  6. Conduct test, review and release test results for products or materials 
  7. Perform and assist in equipment qualification and method validations as needed Perform state proficiency testing and/or client proficiency testing under direct supervision as applicable 
  8. Investigate Out of Specification (OOS), Out of Trend (OOT) and/or non-conforming test results 
  9. Assist in investigations, and preparation of deviation reports, with input from the manager or lead, in a timely manner and implements corrective actions and preventive actions 
  10. Packaging and shipping samples to contracted Laboratories for testing and/or to Clients

Qualifications include:

·

  1. BS or BA in Science 
  2. Medical Technologist license (preferred)
  3. 6 years’ QC experience in a clinical laboratory, microbiology, hematology, blood banking, immunology or QC laboratory preferably in a cGMP/cGTP environment. 
  4. Basic knowledge of Flow Cytometry experience preferred 
  5. Must be proficient in QC test methods/procedures and use of the QC lab equipment 
  6. Working knowledge of GxP regulations and standards Working knowledge of quality systems: Change control, Deviations, CAPA, etc.

 

Apply here

QC Microbiology Associate II || Allendale, NJ || Direct Hire || Full-time

ashishsisodiya45 August 7, 2020
Job Role- Quality Control Microbiology Associate II

QC Micro

Employment Type-Direct Hire/Full-time
Location-Allendale, NJ

Position Summary

The Quality Control Microbiology Associate serves as a support role to clinical and commercial production at the Allendale, NJ facility. The QC EM Associate will provide environmental monitoring data to ensure that quality standards are upheld for all products produced at the facility. 

Core Responsibilities

Under the direction of the Manager, QC Microbiology, responsibilities of the QC Microbiology Associate will include but are not limited to:

Environmental monitoring in controlled environments: 

o Non-viable particulate monitoring using Met One and Climet equipment 

o Active viable air monitoring using SAS equipment 

o Personnel monitoring 

o Surface sampling 

o Passive air monitoring 

· Equipment monitoring: 

o Ensure equipment is in proper working conditions 

o Ensure all equipment is properly maintained/calibrated 

o Program equipment with proper workflows  

· Assist with routine laboratory testing: 

o Plate reads and incubations 

o Growth Promotion 

o Microbial Identifications 

· Shipping of test samples and equipment to contract laboratories for testing 

· Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).

· Writing/conducting investigations pertaining to environmental monitoring and testing 

· Assist in the creation/revision to Standard Operating Procedures, Work Instructions, Forms, and Protocols

Qualifications include:

· BA/BS in a science

· Biotechnology Certificate and/or cGMP experience 

· Minimum 3 years of experience in environmental monitoring within the biopharmaceutical industry 

· Candidate must be familiar with ISO and EU classified environments  

· Proficient with computer software such as 

o Microsoft Office 

o MODA 

o Visio 

· Strong written and oral communication skills 

· Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities

Apply here

QC Microbiology Associate I || Allendale, NJ || Direct Hire || Full-time

ashishsisodiya45 August 7, 2020
Job Role- Quality Control Microbiology Associate I

QC Micro

Employment Type-Direct Hire/Full-time
Location-Allendale, NJ

Position Summary

The Quality Control Microbiology Associate serves as a support role to clinical and commercial production at the Allendale, NJ facility. The QC EM Associate will provide environmental monitoring data to ensure that quality standards are upheld for all products produced at the facility.

Core Responsibilities

Under the direction of the Manager, QC Microbiology, responsibilities of the QC Microbiology Associate will include but are not limited to:

Environmental monitoring in controlled environments:

o Non-viable particulate monitoring using Met One and Climet equipment

o Active viable air monitoring using SAS equipment

o Personnel monitoring

o Surface sampling

o Passive air monitoring

· Equipment monitoring:

o Ensure equipment is in proper working conditions

o Ensure all equipment is properly maintained/calibrated

o Program equipment with proper workflows

· Assist with routine laboratory testing:

o Plate reads and incubations

o Growth Promotion

o Microbial Identifications

· Shipping of test samples and equipment to contract laboratories for testing

· Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).

· Writing/conducting investigations pertaining to environmental monitoring and testing

· Assist in the creation/revision to Standard Operating Procedures, Work Instructions, Forms, and Protocols

Qualifications include:

· BA/BS in a science

· Biotechnology Certificate and/or cGMP experience

· Minimum 3 years of experience in environmental monitoring within the biopharmaceutical industry

· Candidate must be familiar with ISO and EU classified environments

· Proficient with computer software such as

o Microsoft Office

o MODA

o Visio

· Strong written and oral communication skills

· Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities

Apply here

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

 

Apply here