Position Title: Senior Quality Assurance Analyst
Work Location: Lexington MA 02421
Assignment Duration: 12 Months
Position Summary: Primary duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations/validation or development studies. Testing may include but not limited to samples from drug substance/product and various protocol studies using test methods derived from the various compendia and non-compendial sources.
Key Responsibilities:

• The position is expected to maintain operational and GMP readiness of the QC area.
• In addition, the individual will participate in more complex projects, operational excellence initiatives including 5S/lean improvements, method/equipment validation, method transfer and various quality systems (deviations, change controls, investigations) with little to no supervision, and maybe asked to take lead roles for the QC organization on these projects.
• Position is expected to act as a role model for junior staff in the various QC areas.
• In addition, management, coaching, and mentoring of junior staff in the lab will be required.
• Work is performed under general direction with little to no supervision.
• Participates in determining objectives of assignments.
• Plan schedules and arrange activities in accomplishing objectives.
• Work may be reviewed upon completion for adequacy in meeting objectives
• Exerts some influence on the overall objectives and long-range goals of the organization.
• Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.
• Role is responsible for Cell Biology laboratories performing a broad range of techniques such as SDS-PAGE, Western Blot, ELISA, Potency and Bioassays in order to support in-process, release and stability testing.
• Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation.
• Introduction of new equipment and technology to improve sustainability and compliance is expected.
• Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.
• Product testing: Areas of focus on techniques such as Western Blot, SDS-PAGE, ELISA Potency and Bioassays
• Receives assignments in the form of objectives and establishes goals to meet objectives.
• Provides guidance to subordinates to achieve goals in accordance with established policies.
• Work is reviewed and measured based on meeting objectives and schedules.
• Establishes and recommends changes to policies which affect subordinate organizations.
• 40-50% Testing execution, participate in training analysts, trouble shooting of methods
• 20-30%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)
• 10-20% Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
• Complete understanding and application principles, concepts, practices and standards.
• Full knowledge of industry practices.
• Position requires critical thinking.
• MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding Office, LIMS, SAP, Trackwise, EDMS, Compliance and strong science understanding
• Develop solutions to a variety of complex problems.
• May refer to established precedents and policies.
• Works on problems of diverse scopes where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
• Networks with senior internal and external personnel in own area of expertise.
• Represents organization as a prime contact on contracts or projects.
• Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations.
• Contacts external to QC may include: Analytical Development, R&D, Quality Assurance and other Quality functions, Regulatory , Manufacturing, Facilities and Engineering
• The following physical abilities are required in order to fulfill the job duties:
• -Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
• -Ability to work around chemicals (if working around the laboratories)
• -Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
• -Ability to walk and stand for periods of time
• -Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

Qualifications & Experience:

• Typically requires a bachelor’s degree and a minimum of 4+ years of related experience. (science related degree is preferred)
• Excellent communication, interpersonal and organizational skills.
• Ability to work well both independently and in a team environment.
• Ability to prioritize work and multitask.
• Previous experience in a GMP QC role is preferred
• 5S/OE experience
• Method transfers

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 60.00/hr.