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Senior Formulation Specialist
2 months ago
Role Summary:
The Senior Formulation Specialist is a pivotal role within our organization.
- Engages in the production of buffers and straightforward bulk reagents according to established manufacturing protocols with minimal oversight. Involvement in initiatives aimed at process enhancement is expected.
Core Responsibilities:
- Accountable for the examination of all documentation pertinent to the area.
- Oversees the WNS.
- Assists in the production of controls and calibrators, ensuring batch records are completed in accordance with cGMP standards.
- Conducts in-process assays utilizing instruments such as spectrophotometers, pH meters, and clinical analyzers.
- Responsible for the weighing, transferring, and mixing of necessary chemicals.
- Executes product filtration processes.
- Maintains cleanliness of stainless steel tanks through cleaning in place (CIP) and sterilization in place (SIP) methods.
- Prepares glassware and stainless steel tanks for sterilization in an autoclave and operates the autoclave as required.
- Ensures the upkeep of laboratory equipment, including pumps, pH meters, and flow meters.
- Keeps the department lead or manager informed of all relevant issues.
- Monitors inventory levels of common laboratory supplies.
- Performs additional duties as assigned.
- Responds to emergency notifications as necessary.
- Availability for flexible hours, including weekends.
Essential Qualifications:
- High school diploma or equivalent; an Associate's degree is preferred, along with a minimum of 2 years of laboratory experience.
- Fundamental laboratory skills and awareness of safety protocols.
- Understanding of Quality System Regulations is advantageous.
- Experience handling potentially hazardous chemicals and human source materials is required.
- Must be capable of routinely lifting 25 lbs and occasionally lifting up to 50 lbs.
Mandatory Hiring Criteria:
- Compliance with GMP, QSRs, ISO, and IVD regulations in the execution of departmental responsibilities is essential.
- Proficiency in reading and writing English, with the ability to comprehend both written and verbal instructions in English.
- Competence in basic arithmetic operations including addition, subtraction, multiplication, and division across various units of measure.
- Familiarity with Microsoft Word, Excel, and Outlook is necessary.
At Cogent Infotech Corporation, we are committed to advancing our expertise to establish new benchmarks within the industry. Through the ongoing enhancement of our processes and the expansion of our services to adapt to the changing demands across various sectors, we deliver effective, forward-thinking, and comprehensive solutions.
