Position Title: Specialist, QC Equipment Management Location: Summit West, S-12 Duration: 06 Months Shift:6 AM to 4 PM, Sun-Wed.
PURPOSE AND SCOPE OF POSITION: The Specialist, QC Equipment Management is responsible for periodic maintenance and cleaning of GMP Equipment within the S12 QC department. This individual also supports completion of records associated with equipment life cycle management, excursions, and calibration failures.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: • General computer, and organizational skills • General knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP and EP regulations and guidelines as related to the manufacture of cell therapy products • Effective communication (oral and written) • Ability to keep accurate records, strong attention to details, follow instructions, and comply with company policies. • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. Good interpersonal skills are a must. • Proficient in Microsoft Word, Excel, Access, and Power Point. Education and Experience: • Associate degree or higher • 0 to 2 years of relevant work experience. • Have the aptitude to work independently to lead projects and meet deadlines. • Have strong communication skills and relationship building skills. • Understanding of ALCOA+ principles, good documentation, and manufacturing practices.
DUTIES AND RESPONSIBILITIES: • Perform routine cleaning and performance verification (as needed) for laboratory equipment. • Report any equipment malfunctions or issues to the appropriate stakeholders • Support CAPAs, Notice of Event (NOE) creation and investigations associated with equipment performance. • Assist during internal and external audits & keep labs in audit ready state. • Follow ALCOA+ principles, good documentation, and manufacturing practices • All other duties as assigned by management.
The ideal candidate would possess: • Ability to multi-task, prioritize and meet strict timelines. • Ability to review documentation for accuracy, clarity, and adherence to GMP, GDP and/or GLP regulations. • Critical thinking • Ability to complete routine tasks with little or no supervision.
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: $38.00/hr.
