Manufacturing Technician I - Oral Solid Dosage

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.
• Affords assistance with other manufacturing areas as required.
• 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.

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).