Formulation Associate 2nd & 3rd

Sharp Services, LLC; Lee, Northern (MA, KY); Hybrid; USD 27,000 - 50,000; Full time

Job summary

Sharp Services, LLC in Lee, MA is seeking a Formulation Associate II/III to perform formulation operations in a GMP environment. Duties include preparing buffers, operating tanks and autoclaves, and ensuring batch records and SOP compliance.

The role supports start-up/changeover activities, with shifts across 1st, 2nd, and 3rd, including 10–15% shift differentials for some shifts. Associates degree in a science field required or equivalent GMP experience.

Qualifications

• Experience with formulation/compounding processes and equipment in GMP environments.
• Knowledge of cGMP and cGLP practices and regulatory compliance.
• Ability to prioritize multiple projects and follow SOPs and batch records.

Responsibilities

• Operate formulation-related equipment and correct assembly of buffers, medias and solutions.
• Run batch processes and document according to batch records and SOPs.
• Support start-up/changeovers/tech transfer activities following GMP requirements.
• Record deviations, participate in investigations, and suggest corrective actions.
• Cross-train to expand technical skills and assist in process improvements.

Skills

Formulation processes

GMP compliance

cGMP & cGLP

Prioritization

Microsoft Office

Communication

Teamwork

Education

Associates Degree in science

Additional degree considered with depth

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Formulation Associate 2nd & 3rd

Full Time Manual Labor Lee, MA, US

30+ days ago Requisition ID: 1744

Salary Range: $19.58 To $36.59 Hourly

Shift Aviable:

1st: 6:30 am-3:00 pm

2nd: 2:30 pm - 11:00 pm: comes with 10% Shift differential

3rd: 10:30 pm - 7:00 am: Comes with 15% shift differential

Position Summary

Perform all formulation operations in the area of assignment and support start-up/changeovers/tech transfer activities. This position works under the immediate direction of the Formulation Supervisor and all work is conducted following a high standard of GMP compliance and written SOP and batch records.

Duties and Responsibilities

• Operate glass washers and autoclave, prepare buffers and medias and other solutions
• Operate process equipment such as tanks, filtration devices, autoclaves, glass washers, integrity testing and other small equipment
• Daily completion of formulation activities ensuring all scheduled tasks/events are completed
• Formulation process steps including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss
• Initiate the production of batch used for engineering and cGMP production and initiate thawing of the API as required
• Execute Batch Records accurately and complete prior to submission for review
• Author process deviations when they occur within the department, participate in investigations and contribute to identifying corrective and preventative actions
• Cross train to increase technical skills across the department
• Communicate, in a timely manner, to management and clients of issues, challenges as well as opportunities for process improvements
• Other duties as assigned

Regulatory Responsibilities

• Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements
• Conduct all work in compliance with FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance

Supervisory Responsibilities

• N/A

Experience

• Formulation Associate I – Zero to two (0-2) years' experience in a GMP environment performing and using formulation/compounding processes and equipment

Education

• Formulation Associate I – Associates Degree in a science-related discipline or equivalent GMP experience

Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience

Knowledge, Skills & Abilities

• Possess working knowledge offormulation/compounding processes and equipment
• cGMP and cGLP practices
• Demonstrated ability to prioritize multiple projects and activities
• Can perform routine work instructions and trouble shoot routine problems referring more complex issues to Formulation Supervisor
• Experience with Microsoft Office and general computer proficiency
• Effective communication and availability
• Able to work effectively with others

Physical Requirements

• Ability to meet gowning requirements
• Fine and gross motor skills to manipulate tools and equipment
• Ability to remain stationary for continuous prolonged periods of time
• Able to lift 30lbs repeatedly
• Able to wear PPE
• Medically qualified to participate in respirator program
• Use of standard office equipment with or without reasonable accommodation