Essential Duties and Responsibilities
The essential functions include, but are not limited to the following:
- Conduct routine environmental monitoring to assess the cleanliness and sterility of the compounding areas. This includes air sampling, surface sampling, and particle counting to identify and potential sources of contamination or deviations from acceptable limits.
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Assist in the performance of qualification activities for cleanroom personnel and compounding processes e.g. gowning and media fill qualifications.
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Perform routine inspections and testing of raw materials, in-process samples, and finished products to ensure compliance with regulatory standards and company specifications.
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Conduct visual inspections, physical measurements, and analytical testing using various laboratory equipment and techniques.
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Document and report test results accurately and in a timely manner, maintaining detailed records of all quality control activities.
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Identify and investigate deviations, non-conformances, and quality issues, and collaborate with cross-functional teams to implement corrective and preventive actions.
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Participate in the validation and qualification of equipment, processes, and analytical methods.
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Assist in the development and revision of standard operating procedures (SOPs) related to quality control activities.
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Contribute to continuous improvement initiatives aimed at enhancing product quality, efficiency, and compliance.
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Adhere to good manufacturing practices (GMP), safety protocols, and quality system requirements at all times.
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Support internal and external audits, inspections, and regulatory submissions as needed.
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Stay updated on industry regulations, guidelines, and best practices relevant to pharmaceutical quality control.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- Bachelor’s degree in Chemistry, Pharmacy, Biology, or related field.
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Minimum of 2 years of experience in pharmaceutical quality control or a related role.
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Strong understanding of GMP regulations and quality assurance principles.
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Proficiency in laboratory techniques and analytical instrumentation.
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Excellent attention to detail and accuracy in documentation.
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Effective communication and interpersonal skills.
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Ability to work independently and collaboratively in a fast-paced environment.
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Familiarity with regulatory requirements specific to 503B pharmacies is preferred.
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Must be authorized to work in the US.
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Ability to demonstrate a strong commitment to the mission and values of the organization.
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.
- Must be able to remain in a stationary position for long periods of time.
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Needs to occasionally move about the office to access equipment.
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May include minor lifting.