Manufacturing Contractor II
Posted on: March 17, 2023
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.
- With limited Supervision this individual will perform routine
and non-routine manufacturing operations at the Alewife
- Operations including but not limited to work functions in the
area of weigh/dispense, solution preparation, formulation and UF/DF
- 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.
- 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
- 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
- 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
- Provides operational support for cross-functional GMP
activities such as validation qualifications, maintenance
- Provides technical training to junior employees: develops on
the job training requirements for MFG operations
- Familiar with SAP system and transactions related with MFG
- Primary Location (Alewife-Cambridge, Ma); Alternative plant
support (ex. Norton, Ma) may be possible depending on candidate
- Must possess a mechanical and scientific aptitude and be able
to clearly and thoroughly document all work on existing forms and
- 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.
- 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
- 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
Keywords: TalentBurst, Cambridge , Manufacturing Contractor II, Other , Cambridge, Massachusetts
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