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Pharmaceutical Formulation Specialist II
2 months ago
POSITION SUMMARY:
Responsible for the production of pharmaceutical Spray Dried Intermediates (SDI) and Solid Dosage Forms, including tablets, capsules, and granules, while adhering to current Good Manufacturing Practices (cGMP). This role involves executing process documentation in a dynamic manufacturing environment.
KEY RESPONSIBILITIES:
- Ensure cleanliness of work areas and the facility with the support of designated personnel.
- Prepare manufacturing suites and components for the execution of Production Batch Records.
- Act as a verifier on logbooks and related documentation.
- Execute Production Batch Records (PBRs) and Work Orders (WOs).
- Work independently and possess the experience to verify at least one line of unit operations.
- Maintain adequate supplies of Personal Protective Equipment (PPE) and gowning materials in the gowning area.
- Manage cGMP materials inventory in accordance with applicable Standard Operating Procedures (SOPs).
- Revise existing SOPs and create new SOPs as necessary.
- Conduct equipment qualification activities.
- Clean and visually inspect processing equipment, tools, and utensils for cleanliness, documenting these activities appropriately.
- Ensure all cGMP equipment and components are properly labeled.
- Perform additional technician responsibilities as required.
EXPERIENCE REQUIRED:
A minimum of one (1) year of production experience in the pharmaceutical sector is required. A solid understanding of current Good Manufacturing Practices (cGMP) and familiarity with cGMP documentation, spreadsheets, and software applications is preferred. Experience in the pharmaceutical or biotech industries is highly desirable. A proven ability to produce high-quality work with a strong attention to detail is essential. Candidates should be capable of managing multiple tasks and adapting to changing priorities in a fast-paced manufacturing setting. Proficiency in Microsoft Office Suite (Word and Excel) is necessary, along with effective written and interpersonal communication skills.
PHYSICAL REQUIREMENTS:
The work environment involves the production of pharmaceutical dosage forms in a small-scale manufacturing suite. The position requires frequent standing (up to 8 hours) and the ability to perform ordinary ambulatory skills and physical coordination to navigate office, laboratory, and manufacturing locations. The role necessitates the ability to stand, walk, stoop, kneel, and crouch for extended periods, as well as the capability to lift, carry, and move medium to heavy weights of 35-50 pounds. Candidates must possess arm, hand, and finger dexterity, including the ability to grasp and manipulate objects for prolonged periods. Visual acuity is required for using a keyboard, computer monitor, operating laboratory equipment, and reading materials for extended durations. The ability to sit, reach with hands and arms, talk, and hear for prolonged periods is also necessary.
EDUCATIONAL REQUIREMENTS:
An accredited High School Diploma or GED is required. An Associate's degree and/or military experience is preferred.
WORK HOURS:
This is a full-time position with standard hours from 6:00 AM to 3:00 PM, Monday through Friday. Overtime may be possible, though not likely.
