Shift: This position is scheduled for Wed- Sat (4pm - 2am)
PURPOSE AND SCOPE OF POSITION: The Quality Assurance Label Control Specialist at the S-12 Cell Therapy manufacturing facility is responsible for supporting site Label Control activities at S-12 in accordance with policies, standards, procedures and Global cGMPs. Functional responsibilities include performing in process and drug product label printing activities; ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO). The Quality Assurance Label Control organization is responsible for the establishment, maintenance and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities for achieving quality policies and objectives. This organization supports the S-12 facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: • Must have knowledge and experience with GMP, Quality, and compliance. • Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills. • Requires moderate direction to complete more complex tasks; completes routing tasks with little or no supervision. • Must be time organized and possess an independent mindset. • Good understanding of electronic document management and manufacturing execution systems. • Has advanced computer skills to increase department’s productivity, as well as broadening technical and scientific knowledge. • Confident in making decisions for non-routine issues. • Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies. • Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned. • Builds relationships and effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross functional teams. Represents department in internal and external cross-functional teams. • Contributes to goals within the work group. • Able to recognize conflict and notify management with proposed recommendations for resolution. • Able to prepare written communications and communicate problems to management with clarity and accuracy. • Able to produce data reports with precision. • Able to multi-task. • Able to support internal and health authority inspections of facility
Education and Experience: B.S. Degree required, minimum 2 years relevant work experience Equivalent combination of education and experience acceptable
DUTIES AND RESPONSIBILITIES: • Supports all activities for the Quality Assurance Label Control group. • Responsible for issuing clinical and commercial in-process and final product labels for labeling operations. • Responsible for ensuring accurate printed information on labels in compliance with health authority requirements. • Coordinates with production teams to ensure timely issuance of labels. • Performs training of label control and issuance requirements for internal personnel as needed. • Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required. • Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned. • Provides support during internal and health authority inspections and audits of facility. • Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management. • Performs supplemental investigations/projects as required by Management. • Maintains knowledge of current GMPs and regulatory guidelines.
WORKING CONDITIONS (US Only): Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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: $32.00/daily.
