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Specialist Quality Assurance

West Greenwich, RI
Top 3 Must Have Skill Sets:        
  • Previous QA oversight of manufacturing, analytical and engineering activities; experience in investigations and quality systems process knowledge. (beginner to intermediate level of experience)
  • Biotech- quality assurance/manufacturing experience (insight into quality assurance) (beginner to intermediate level
  • Ability to gather relevant information to understand and solve complex problems and make scientific risk-based decisions. (troubleshooting experience/problem solving/ to best provide a quality assurance concepts)
  • soft skills
  • Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with peers, manufacturing partners, and management staff. This role requires a high level of communication as there are 20 people so the candidate will need to be able to effectively communicate what was done and be able to pick up and ask questions from the previous shift.
Day Day Responsibilities:        
  • ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing.
  • Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
  • Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
  • Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Nonconformance, and Corrective Action/Preventative Actions (CAPA) records.
  • Establish and enable LEAN practices.
  • Ensures that deviations from established procedures are investigated and documented per procedures.
  • Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Alerts senior management of quality, compliance, supply and safety risks.
Summary
Candidate must be onsite
Candidate must be vaccindated

Quality Assurance On-the-Floor position Shift 3 (4 days a week Tuesday through Friday 10 hours per day 10pm – 8am

Ideal candidate- Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies. GMP Bio pharmaceutical Experience either manufacturing or Quality– must have minimum 2-3 years. Quality Experience of GMP Operations – 2 year

The Quality Assurance Specialist will be responsible for PQA On the Floor in support of Manufacturing activites. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. Quality Assurance On-the-Floor position Shift 3 (4 days a week Tuesday through Friday 10 hours per day 10pm – 8am provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regard to compliance and quality systems with the adaptability to support alternate shifts as the business need requires.
Responsibilities include the following:
  • Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
  • Ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
  • Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Standard Operating Procedures (SOP), Batch Records, Nonconformance, Corrective Action/Preventative Actions (CAPA),
  • Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
  • Establish and enable LEAN practices.
  • Oversee and provide guidance during on-the-floor analytical testing.
  • Ensure that changes that could potentially impact product quality are assessed according to procedures.
  • Ensure that deviations from established procedures are investigated and documented per procedures.
  • Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Alert senior management of quality, compliance, supply and safety risks.
  • Complete required assigned training to permit execution of required tasks.
  • Drive operational improvement initiatives, programs and projects.
Basic Qualifications
Doctorate degree
OR
Master’s degree and 1 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
OR
Bachelor’s degree and 2 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
OR
Associate’s degree and 5 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience
OR
High school diploma / GED and 7 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience

Preferred Qualifications
  • Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
  • Previous QA oversight of manufacturing, analytical and engineering activities
  • Experience in investigations, change controls, and CAPAs processes system knowledge
  • Direct Validation experience with pharmaceutical or biopharmaceutical processes
  • Ability to evaluate compliance issues and interact with regulatory inspectors
  • Experience and training in EDMQ, Trackwise, Maximo, LIMS
  • Experience in managing multiple, competing priorities in a fast-paced environment
  • Experience leading and/or managing teams
  • Direct bulk drug substance and drug product experience
  • Ability to solve complex problems and make scientific risk-based decisions
  • Experience representing this company while interacting with representatives of regulatory agencies
  • Experience of trending analysis
  • Demonstrated proficiency using Excel, Word and Power Point

 "This posting is for Contingent Worker, not an FTE"

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