Specifications Writer jobs in Binghamton, NY

SUMMARY OF POSITION 

The Quality Specifications Scientist is responsible for development and life-cycle management of the quality control testing strategy for raw materials, intermediates, finished product, stability samples, and components.  Identifies critical material performance parameters and regulatory requirements and develops appropriate material specifications for incorporation into regulatory filings and use in ongoing quality control testing.  Ensures that specifications are developed, authored, and managed in compliance with local procedures and industry regulation.  

ORGANIZATION STRUCTURE

The Quality Specifications Scientist directly reports to the Quality Assurance Laboratory Lead. 

RESPONSIBILITIES

• Responsible for all phases of development and life-cycle management of material specifications and supporting documents for raw materials, intermediates, finished products, and components supporting new business, technology transfer, and product development.
• Review compendia for method and testing requirements along with critical material performance characteristics to develop material specifications to ensure appropriate and consistent product performance.
• Review compendia on a regular basis for applicable updates.
• Works with management and QA to develop, author, and implement formal procedures (SOPs) defining work processes.  Develop work processes and author procedures that are consistent with Agency guidance and industry standards.  
• Manage specification development, and life cycle in accordance with local procedures, change control system, and industry regulation. 
• Perform training as required to effect efficient installation of material specifications.  
• Develops and maintains KPIs to monitor project progress, timeliness, accuracy, rework, and customer satisfaction.
• Focuses energy on activities consistent with the vision and objectives set by department, site, and corporate management
• Behaves with a sense of urgency dictated by business needs, getting things done right and accurate in a timely manner
• Utilizes LEAN principles to simultaneously effect compliance and productivity.
• Demonstrate commitment to personal and professional development for self and laboratory personnel
• Perform other duties and responsibilities as required by business needs

QUALIFICATIONS

• BS in Chemistry or related science (Prefer MS in Chemistry, Engineering or related scientific field)
• 7-10 years experience in the pharmaceutical industry strongly preferred in  Quality Control or Quality Assurance (alternately an equivalent combination of education and experience), including experience with analytical procedures for raw materials, intermediates, finished products, and packaging components.
  • Strong leadership, communication, interpersonal, organizational, decision-making, technical-writing, and investigational skills
  • Expertise in cGMP regulations, ICH guidelines and industry standards.
  • Ability to develop and interpret procedures, guidance, and regulations relating to a pharmaceutical QC environment, including; USP/NF, EP, JP, validation, raw material and finished product testing, instrumentation, solution preparation and standardization, and laboratory workflow is strongly preferred
  • Advanced computer skills, specifically Microsoft Office, QUMAS, SAP, and ComplianceWire preferred.
  • Safety 
    GMP DECISION-MAKING AUTHORITY
     
    The Quality Specifications Scientist has authority to manage all aspects of material specification life-cycle from inception through development, commercialization and retirement.
     
     
    This role will offer a base salary that is commensurate with experience and demonstrated skills in the range  $70,000 - $80,000
    “An Equal Opportunity Employer, including disability/vets.”