Manufacturing Technician II - Oral Solid Dosage

Alcami Corporation•Wilmington, NC

2d•Onsite

About The Position

The Manufacturing Technician II 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 II OSD 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 II OSD employs acceptable techniques while working in manufacturing environments, including PPE gowning.

Requirements

High school diploma or GED required.
3+ 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.
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).

Nice To Haves

Associate’s degree preferred.
Candidates with life sciences or engineering degrees will be considered without manufacturing experience.

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.