Jobs

Description

Duties:

• Operate in a controlled GMP environment.
• Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.).
• Ensure compliance with established internal and external control procedures.
• Participates in the execution of Drug Product activities to support the production/manufacturing schedule.
• Demonstrates operational proficiency in Drug Product-related process equipment, as required per business needs.
• Initiate and supports the closure of Deviation Reports.
• Supports the initiation and closure of CAPA and CR Tasks as required per business needs.
• Review in-process and completed documents for accuracy and to make sure batch records are turned in to area management within specified days of completion.
• Responsible for revising and originating production records, standard operating procedures, protocols and reports.
• Supports the ongoing continuous improvement within the Drug Manufacturing Process.
• May collaborate with process science teams, analytical testing personnel, microbiological support team, facilities and sanitization groups in support of Quality Record investigations/closure.

Experience Minimum Required:

• 0-3 years of experience with pharmaceutical or biotechnology manufacturing processes; or equivalent education, training, and experience.

Preferred:

• Hands-on skills with Aseptic technique, cleanroom gowning and extensive knowledge of Good Manufacturing Practices (GMPs).
• Hands-on skills with aseptic fill finish operation.
• Hands-on experience with automated filling/capping machine, and Lyophilizer.

Competencies Key Competencies: ·

• Integrity, Trust, Ethics, Values
• Results oriented · Strategic Skills
• Organizing/Priority Setting
• Communication skills
• Attention to detail
• Decision Quality
• MS Word Proficient
• Flexibility
• Interpersonal Savvy
• Negotiating
• Problem Solving
• Listening & Approachability
• Partnering

Work Environment & Physical Demands

• This section of the job description is required by the American with Disability Act, (ADA).
• The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job.
• The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship.
• A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”
• Ability to stand for extended periods of time Must be able to lift up to 25 pounds at times

Minimum Required:

• High School Degree or Equivalent

 Preferred:

• Bachelor’s degree in biological sciences, chemical engineering or related discipline