Manufacturing Contractor II

Company: TalentBurst
Location: Cambridge
Posted on: March 17, 2023

Job Description:

Job Description

Job Title: Senior Manufacturing Associate
Location: Alewife (Cambridge, MA)
Duration: 12 months extendable contract

TalentBurst offers comprehensive benefits to temporary employees at a cost, they include healthcare, dental, vision, 401k and any State or Federal mandated time off.

Job Description:

Job Summary:

• With limited Supervision this individual will perform routine and non-routine manufacturing operations at the Alewife Manufacturing Facility.
• Operations including but not limited to work functions in the area of weigh/dispense, solution preparation, formulation and UF/DF processing.
• Operates production equipment according to SOPs for the production of clinical and/or commercial products.
• Requires technical capabilities to interact with support groups (Facilities, Process Development, and Validation etc.) to ensure accurate and well managed transfer of process changes.
• Support floor operations to ensure safety, aseptic operations and compliance are maintained at all times. ccountabilities:
  • This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP) and Batch Records. Responsibilities include:
  • Troubleshoot and resolve process related issues and interact with support groups to ensure production targets are met and product and process comply with GMPs, product licenses and corporate policies.
  • Ensure all operations and documentation conform to GMP standards and that all SOPs and batch records are maintained to reflect current manufacturing methods.
  • Use technical writing skills to own and complete deviations, CAPAs and change controls as required.
  • Identify and implement continuous improvement projects utilizing independent project management skills.
  • Generation and progression of work orders to support GMP operations; coordinates work activities with support teams to minimally impact schedule adherence
  • Performs MFG documentation requests (batch records, logbooks); Performs review and approval of manufacturing documentation to ensure compliance.
  • Review and revise MFG documentation to support changes or continuous improvement initiatives
  • Performs work with adherence to site safety procedures and requirements; Generates safety incident reports where applicable
  • Provides operational support for cross-functional GMP activities such as validation qualifications, maintenance activities, etc.
  • Provides technical training to junior employees: develops on the job training requirements for MFG operations
  • Familiar with SAP system and transactions related with MFG material consumption
  • Primary Location (Alewife-Cambridge, Ma); Alternative plant support (ex. Norton, Ma) may be possible depending on candidate availability
    Knowledge/Experience/Skill:
    • Must possess a mechanical and scientific aptitude and be able to clearly and thoroughly document all work on existing forms and records.
    • Bachelors of Science (BS) degree preferred and 2-5 years' experience in a regulated GMP facility, where safety and the ability to maintain a compliant, highly effective and efficient product environment is critical.
    • High level of attention to details in both operations and documentation is required. Scope:
      • ll activities in support of internal manufacturing at the Alewife manufacturing facility.
        Competencies.
      • Strong organizational skills, attention to detail, and an ability to work in a team setting preferred.
      • Excellent communication skills, adaptable, and flexibility with work schedules required. Physical/Environmental Factors:
        • Must be able to execute strenuous, sometimes repetitive physical work.
        • bility to lift objects up to 50 lbs, and push/pull objects including bulk materials up to 250 lbs with assistance.
        • bility to wear half face and full face respirators as required.

Keywords: TalentBurst, Cambridge , Manufacturing Contractor II, Other , Cambridge, Massachusetts