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Senior Analytical Chemist in Devens, MA at Apex Life Sciences

Date Posted: 11/22/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Devens, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/22/2018
  • Job ID:
    905646

Job Description


Responsibilities

  • Responsible for the design, development, qualification, validation, and implementation of analytical procedures in support of research, GMP production, and stability testing.
  • Develops efficient and selective analytical procedures (with emphasis on HPLC and GC) for assigned projects. Prepares qualification and validation protocols and reports for analytical procedures and instrumentation. 
  • Performs sample analysis and reviews data packages. 
  • Documents all analyses per SOPs. 
  • Prepares high quality written documentations (notebooks, SOPs, and analytical procedures) and assists with regulatory documentation. 
  • Troubleshoots analytical instrumentation. 
  • Communicates effectively in verbal and written form on research results and plans. 
  • Volunteers to assist with task not directly related to a specific project. 
  • Demonstrates initiative in handling responsibilities. 
  • Contributes to the technical growth of the department and company. 
  • Attends project meetings and prepares project updates. 
  • Participates in self-development activities. 
  • Demonstrates technical proficiency and self-assuredness in applying cGMP standards. 
  • Applies cGMP concepts in association with department specific responsibilities. 
  • Ensures all documentation produced is in compliance with cGMP standards. 
  • Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed. 
  • Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc. 
  • Follows and abides by all EH&S policies, practices, and procedures in association with department specific responsibilities. 
  • Demonstrates technical and procedural proficiency and self-assuredness in applying EH&S standards. 
  • Responsible for contributing to audit readiness and for participating in EH&S audits with internal Company groups, regulatory agencies, and customers. 
  • Responsible for reporting all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated. 
  • Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department. 
  • Support the Company’s commitment for environmental health & safety by applying ISO 14001, OHSAS 18001, and Sustainability 2025 principals into daily activities. 
  • While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity. 
  • Regularly works with moving mechanical parts and may work with toxic or caustic chemicals. The work may be performed in humid areas with low or high temperatures. 


Requirements

  • BS in Analytical Chemistry or equivalent with 5-7 years related experience in a pharmaceutical industry. 
  • MS in Analytical Chemistry or equivalent with 3-5 years related experience in a pharmaceutical industry. 
  • Ability to write clear and concise technical reports. 
  • Good understanding of Microsoft Office and statistical software. 
  • Demonstrates ability to exercise good judgment and make decisions quickly. 
  • Good written and verbal communication skills. 
  • Experience with common analytical techniques such as HPLC, GC, LC-MS, and GC-MS. 
  • Must have solid Method Development & Method Validation

For immediate consideration, please email your resume to ESchaffer@apexlifesciences.com with the subject 'Senior Chemist' 

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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