Job Title: Batch Record Reviewer II Duration: 6 months Location: Fremont, CA, 94555 Shift timing: 1st Shift: Mon-Fri, 8:00 AM-5:00 PM
Duties:
Works independently to provide quality assurance oversight of any area assigned where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs) including Quality Control Systems and areas.
Demonstrates a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes.
Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to equipment and processes, risk management, and ensuring documentation and investigations meet all requirements.
With autonomy and authority, makes difficult decisions with little time for deliberation which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas.
Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls.
This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business.
Performs independent technical review of documentation during and post-execution of cGMP activities.
Ensures all specifications are met and that applicable requirements are completed and acceptable.
Ensures all issues/documentation associated with each process in assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.
Analyses and reports findings to appropriate departments.
Skills:
Some Team Lead and/or Supervisory experience.
Attention to detail, good organizational and interpersonal skills, and problem-solving skill.
Ability to prioritize and work under pressure.
Ability to work effectively and to respond quickly in a fast-paced environment.
Demonstrated proficiency in MS Office (MS Word, and Excel) programs and associated computer programs.
Knowledge of SAP.
Technical knowledge of manufacturing systems, methods, and procedures.
Must have excellent written and verbal communication skills.
Awareness and understanding of Manufacturing processes.
Education:
Bachelor’s degree in Life Sciences or Engineering
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
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 starting pay is: $34.00/hr.
