Position Title: Manufacturing Associate
Work Location: Newark, CA
Duration: 12 months
Work Arrangement: Onsite

Position Summary: Operate in a controlled GMP environment. Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.).

Key Responsibilities:

• 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.

Qualification & Experience:

• 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

Working Conditions & Physical Demands (If Applicable): 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

Education: Minimum Required: High School Degree or Equivalent Preferred: Bachelor’s degree in biological sciences, chemical engineering or related discipline

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $28.37/hr - $29.57/hr.