Quality Control Analyst II

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Location

Chelsea, MA

Summary

The Quality Control Analyst is responsible for executing QC testing and related analytical activities supporting product development, release and stability. This individual conducts routine and non-routine chemical and physical analyses of raw materials, in-process materials and drug products according to standard operating procedures.

Full Description

The Quality Control Analyst is responsible for executing QC testing and related analytical activities supporting product development, release and stability. This individual conducts routine and non-routine chemical and physical analyses of raw materials, in-process materials and drug products according to standard operating procedures. The Quality Control Analyst compiles data for documentation of test procedures that may include stability program testing and formulation studies, participates in the preparation of investigations, summaries and reports, and reviews data obtained for compliance to specifications and reports out-of-trend and/or out-of-specification results. The Quality Control Analyst revises and updates standard operating procedures as needed.

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Operates analytical instrumentation (i.e. HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, KF).
  • Statistically and critically analyzes data for trending and reporting into regulatory filings. 
  • Participates in Laboratory and/or Quality Investigations.
  • Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration.
  • Participates in the construction and/or revision of SOPs. 
  • Assists in the writing and updating of analytical test procedures, protocol, log books and checklists. 
  • Responsible for identifying and alerting a supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions. 

Education and/or Experience:

  • Bachelor’s Degree in Physical or Chemical Sciences (life sciences) required.
  • Minimum of 2-5 years of experience in a cGMP regulated environment required.
  • Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred.

Supervisory Responsibilities: none

Qualifications:

  • Extensive experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data and statistical analyses required.
  • Demonstrated ability to lead and/or author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required.
  • Ability to troubleshoot and repair analytical instrumentation such as HPLCs and UPLCs preferred.
  • Experience with analytical method development and validation preferred.
  • Familiarity with executing Standard Operating Procedures in a GMP setting required.
  • Chromatography skills using Empower and/or ChemStation required.
  • Critical understanding of the importance of documentation and data traceability required.
  • Working knowledge of cGMP’s and their application to Quality Control required.

Computer Skills:

  • Experience with MS Suite

Certificates, Licenses, Registrations: none required

Other Skills and Abilities:

  • Excellent oral and written communication skills.
  • Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities.
  • Demonstrates dedication to documentation/data traceability and strong attention to detail.
  • Demonstrates appropriate safety consciousness.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Ability to lift up to 20 lbs.
  • Ability to stand for long periods of time.
  • This position requires minimal travel; average travel for this position is ≤10% with some variation based upon the demands of the business imperatives.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Ability to work safely and conscientiously in a laboratory environment; wear appropriate personal protective equipment; communicate with others in the laboratory to mutually ensure continued safe laboratory practices.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.