Senior Technician 1, Manufacturing

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POSITION SUMMARY:

The Senior Technician 1, Manufacturing will be responsible for performing routine and complex tasks for the GMP manufacturing and packaging of pharmaceutical products. The successful candidate will be familiar with best practices for cGMP assembly and packaging of combination pharmaceutical products. This individual is responsible for the documentation and the hands-on execution of production activities related to assembly, final packaging, and inspection of manufactured pharmaceutical products.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

• Responsible to adhere to all manufacturing and quality processes and requirements.

• Receives and distributes supplies in the manufacturing area.

• Operates and monitors manufacturing equipment to produce clinical and commercial pharmaceutical products under minimal supervision.

• Performs the assembly, final packaging, and inspection of pharmaceutical products.

• Assembles products following all current Standard Operating Procedures (SOPS) and Work Instructions (WIs), while meeting manufacturing goals and metrics.

• Demonstrates and applies a solid understanding of Lean Manufacturing and related principles.

• Understands and applies flex strategy during day-to-day manufacturing and rotates when necessary.

• Ability to maintain accurate records following Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP) guidelines including training files and shop floor paperwork

• Able to successfully navigate electronic systems such as Microsoft 365 (Outlook, Work, Excel) and electronic Batch Records

• Will be trained on, and must be willing to take on responsibilities of DEA Monitor.

• Provides feedback to management on recommendations for procedural and process improvements.

• Perform other related duties as assigned. =

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• High School Diploma or equivalent combined with 2-4 years of experience working in a production environment, ideally in the medical device or pharmaceutical industry

• An equivalent combination of experience and education may be considered.

• Strong knowledge of Good Documentation (GDP) and current Good Manufacturing (GMP) Practices.

• Must be able to work in a controlled or clean room environment requiring special gowning.

• Critical understanding of the importance of documentation and data traceability.

• Ability to train others on manufacturing processes and electronic systems.

• Demonstrates attention to detail.

• Ability to multi-task and adjust priorities, as necessary.

• Excellent organizational skills.

• Must be able to work well independently and in a team environment.

• Excellent communication skills, both verbal and written.

• Able to perform physical activity such as standing for long periods of time, walking, and working with hands.

ENVIRONMENTAL CONDITIONS:

Physical Activities: On a continuous basis, be at a desk for a long period of time; intermittently answer the telephone and type on a computer. Some walking and lifting up to 30 lbs. may be required. The noise level in the work environment is usually low to moderate.

The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job.

Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.

TRAVEL:

Travel may be required up to 5% of your time.