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Pharmaceutical Formulation Specialist II
2 months ago
POSITION SUMMARY:
Responsible for the execution of current Good Manufacturing Practices (cGMP) in the production of pharmaceutical Spray Dried Intermediates (SDI) and Solid Dosage Forms, including tablets, capsules, and granules. This role involves meticulous process documentation within a dynamic manufacturing environment.
KEY RESPONSIBILITIES:
- Ensure cleanliness of workspaces and facilities with the support of designated personnel.
- Prepare manufacturing areas and components for the execution of Production Batch Records.
- Authorize verification on logbooks and related documentation.
- Execute Production Batch Records (PBRs) and Work Orders (WOs).
- Work independently and serve as a verifier on 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 procedures.
- Clean and visually inspect processing equipment, tools, and utensils for cleanliness per relevant SOPs, documenting these activities.
- Ensure proper labeling of all cGMP equipment and components.
- Perform additional technician duties as required.
EXPERIENCE REQUIRED:
A minimum of one (1) year of production experience in the pharmaceutical sector is essential. 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 valued. A proven ability to deliver high-quality work with precision is crucial. Candidates should be adept at managing multiple tasks and adapting to changing priorities in a fast-paced manufacturing setting. Proficiency in Microsoft Office Suite (Word and Excel) is required, along with effective written and interpersonal communication skills.
PHYSICAL REQUIREMENTS:
Work Environment:
Involves the production of pharmaceutical dosage forms within a small-scale manufacturing suite.
The position necessitates frequent standing (up to 8 hours) and ordinary ambulatory skills, along with physical coordination to navigate office, laboratory, and manufacturing locations. The role requires the ability to stand, walk, stoop, kneel, and crouch for extended periods; handling medium to heavy weights (35-50 pounds); and possessing arm, hand, and finger dexterity for prolonged tasks. Visual acuity is necessary for using a keyboard, computer monitor, operating laboratory equipment, and reading materials over extended durations. The ability to sit, reach with hands and arms, talk, and hear for extended periods is also required.
EDUCATIONAL BACKGROUND:
An accredited High School Diploma or GED is required. An Associate's degree and/or military experience is preferred.
WORK SCHEDULE:
This is a full-time position with standard hours from 6:00 AM to 3:00 PM, Monday through Friday, with potential for overtime, though it is not anticipated.
