cGMP Manufacturing Technician — Batch Operations

Medical Products Labs

Philadelphia (Philadelphia County)

On-site

USD 25,000 - 39,000

Full time

4 days ago
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Job summary

Medical Products Labs is seeking a Manufacturing QA Associate to execute batch records and SOPs, operate and clean equipment, and perform in-process tests with strict adherence to cGMP/FDA standards. You will document results accurately, weigh materials precisely, and maintain a clean, safe work area to support production teams.

The role requires attention to detail, ability to work with minimal supervision, and English proficiency for clear communication.

Qualifications

  • High school diploma or equivalent.
  • Preferred: 1+ year of QA or cGMP manufacturing experience with working knowledge of FDA and cGMP requirements.
  • Strong attention to detail and documentation accuracy; able to execute with minimal oversight.
  • Proficient in English; clearly read, understand, document, and present information; respond effectively to questions from other departments.
  • Comfortable with calculations including addition, subtraction, multiplication, division, averages, percentages, and fractions.
  • Willing to work first and/or second shift, plus overtime as needed; capable of sampling/inspection tasks.

Responsibilities

  • Execute manufacturing steps exactly as written in batch records and SOPs; follow all company policies and cGMP/FDA regulations.
  • Set up, operate, and disassemble/clean equipment and suites; sanitize rooms to SOP standards.
  • Perform in-process testing and quality checks; identify and report deviations promptly.
  • Accurately complete batch documentation, equipment logs, line clearances, and lab notebooks.
  • Weigh and stage raw materials and components for production batches with precision.
  • Maintain a clean, safe work area; report accidents or unsafe conditions.

Skills

Attention to detail
Documentation accuracy
English proficiency
Mathematics
Problem solving
Team collaboration
Multitasking
Clear communication

Education

High school diploma or equivalent

Job description

Your day at a glanceYou clock in, pick up the Master Batch Record from your manufacturing supervisor, review the steps, and prepare the suite. You verify equipment cleanliness and assembly per SOPs, weigh materials and components precisely, and begin the run. Throughout the batch, you conduct and document in-process tests, complete line clearances, and keep equipment logs and lab notebooks accurate and current. If anything looks off, you escalate immediately. When the batch is finished, you notify your supervisor, close out the record with your signature, and gear up for the next assignment.Supervisory responsibilitiesNone.What you'll handleExecute manufacturing steps exactly as written in batch records and SOPs; follow all company policies and cGMP/FDA regulations.Set up, operate, and disassemble/clean equipment and suites; sanitize rooms (walls, floors, ceilings) to current SOP standards.Perform required in-process testing and visual/quality checks; identify and report deviations and quality issues promptly.Accurately complete batch documentation, equipment logs, line clearances, and lab notebooks.Weigh and stage raw materials and components for production batches with precision.Maintain a clean, orderly, and safe work area; report accidents, unsafe conditions, and unusual circumstances to the manufacturing manager/supervisor.Collaborate effectively while also working independently as tasks require.Carry out additional duties as assigned by management.QualificationsHigh school diploma or equivalent.Preferred: 1+ year of QA or cGMP manufacturing experience with working knowledge of FDA and cGMP requirements.Strong attention to detail and documentation accuracy; able to execute with minimal oversight.Per FDA expectations, must be free from illnesses/conditions that could compromise product safety or quality (e.g., contagious illness, bleeding disorders, open lesions, flaking/peeling skin).Able to wear required personal protective equipment.Communication and mathProficient in English; clearly read, understand, document, and present information; respond effectively to questions from other departments.Comfortable with calculations including addition, subtraction, multiplication, division, averages, percentages, and fractions.Problem-solving and work styleDetect issues early and choose effective solutions; ask the right questions to fully understand situations.Logical, service-oriented mindset with strong organization and reliability; able to prioritize, multitask, and meet deadlines.Willing to work first and/or second shift, plus overtime as needed; capable of sampling/inspection tasks.Interpersonal strengthsOwnership of work quality; team-focused collaborator who supports cross-functional goals.Excellent listening and comprehension; provides clear directions/instructions when needed.Calm under pressure; adapts positively to change; maintains professional appearance and positive attitude.Comfortable partnering with other departments to ensure successful manufacturing/packaging outcomes.Legal and safety notices**PHYSICAL DEMANDS**The physical demands described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to stand for 8 hours and use hands to finger, handle, or feel. The employee frequently is required to reach with hands and arms. The employee is required to stand, walk, bend and talk or hear. The employee must occasionally lift, push or pull up to 50 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.**WORK ENVIRONMENT**The work environment characteristics described in this job description are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The noise level in the work environment is usually moderate to loud****| || |
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