Manufacturing Technician 1

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

The Manufacturing Technician I - Oral Solid Dosage (OSD) is accountable for results in a fast-paced environment and assists with the manufacturing of oral solid dose products for commercial distribution. The Manufacturing Technician I performs the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician I employs acceptable techniques while working in manufacturing environments, including PPE gowning.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Thursday, 6:30am - 5:00pm.

Responsibilities

• Follows applicable SOPs and cGMPs to perform assigned duties and tasks.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Performs applicable manufacturing techniques and technologies per SOPs and cGMPs.
• Performs manufacturing technologies and operation of manufacturing and material handling equipment.
• Documents activities in real time on controlled documentation and legibly, per SOPs and cGMPs.
• Performs in-process testing, weight checks, component counting and basic math calculations.
• Performs cleaning of rooms, tools, and equipment.
• Assists with other manufacturing areas as required.
• Performs activities right first time in areas of Solid Oral Dosage: Microencapsulation, Blending, and Bulk Packaging.
• Applies job skills, company policies and SOPs to complete a variety of tasks.
• Follows general instructions on routine work, detailed instructions on new projects or assignments.
• Follows all Safety requirements and leads by example a safety-first culture.
• Maintains accurate and detailed production documentation in compliance with GMP, FDA regulations, and Alcami's internal policies.

• Works occasional hours outside of scheduled shift based on business needs, which may include weekend work.

• Other duties as assigned.

Qualifications

• High school diploma or GED required. Associate’s degree preferred.
• 1+ years of relevant experience preferred (Drug Substance manufacturing experience will be considered).
• Prior manufacturing work environment required.
• cGMP or prior work experience in a regulated environment required.
• Prior pharmaceutical or CDMO experience required.

Knowledge, Skills, and Abilities

• Good verbal and written communication and documentation skills required.
• Applies job skills, company policies, and SOPs to complete a variety of tasks.
• Good detail orientation and organizational skills required.
• Good problem-solving and basic trouble-shooting ability required.
• Ability to perform basic math calculations.
• Ability to read and comprehend detailed written instructions required.
• Ability to move materials throughout the facility using appropriate methods and equipment required.
• Proficiency in basic computing skills required.
• Ability to use the appropriate PPE based on product (i.e., PAPR, Supplied Air Respirator).

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met or encountered 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; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 25 pounds, frequently lift and/or move up to 50 pounds, occasionally lift and/or move up to 75 pounds and occasionally lift and/or move over 75 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes, or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Based on product, the use of PAPR or supplied air respirator may be required. The use of tight-fitting respirators limits facial hair for proper protection. Regulations may require employees to participate in routine medical surveillance. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.