Spherion Staffing has partnered with a bio-pharmaceutical industry leader to recruit for this role. The primary purpose of this role is to review documentation of the Process Development team to ensure compliance with regulatory requirements.Responsibilities:* Review for compliance and approve all documentation for Research Grade and Highly Documented products.* Write up deviations and investigations.* Write and review all SOPs for Process Development team.* Review records related to production and process development. * Follow GMPs and SOPs to ensure company compliance. * Maintain applicable product inventories.* Summarize data.* Write Plasmid DNA evaluation summaries.Working hours: 8:00 AM - 5:00 PMSkills:* Must have previous technical writing experience in a lab setting.* Experience working in a GMP facility or pharmaceutical environment.* Experience with GMPs and SOPs as applicable to manufacture of Plasmid DNA* Technical writing and reviewing abilities. * Attention to detail and commitment to compliance.* Ability to identify and document scientific deviations.* Inventory maintenance.Education:AssociateExperience:1-4 yearsQualifications:* Associates degree.* Between 1 - 3 years experience in related role. www.spherion.com/applySpherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. No one works harder for you than Spherion. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.
Spherion Staffing has partnered with a bio-pharmaceutical industry leader to recruit for this role. The primary purpose of this role is to review documentation of the Process Development team to ensure compliance with regulatory requirements.Responsibilities:* Review for compliance and approve all documentation for Research Grade and Highly Documented products.* Write up deviations and investigations.* Write and review all SOPs for Process Development team.* Review records related to production and process development. * Follow GMPs and SOPs to ensure company compliance. * Maintain applicable product inventories.* Summarize data.* Write Plasmid DNA evaluation summaries.Working hours: 8:00 AM - 5:00 PMSkills:* Must have previous technical writing experience in a lab setting.* Experience working in a GMP facility or pharmaceutical environment.* Experience with GMPs and SOPs as applicable to manufacture of Plasmid DNA* Technical writing and reviewing abilities. * Attention to detail and commitment to compliance.* Ability to identify and document scientific deviations.* Inventory maintenance.Education:AssociateExperience:1-4 yearsQualifications:* Associates degree.* Between 1 - 3 years experience in related role. www.spherion.com/applySpherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. No one works harder for you than Spherion. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.
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