QA CTO Label Specialist Apply
Label Control Specialist (Manufacturing Facility) Responsible for supporting site Label Control activities in accordance with BMS 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 labelling activities for Cell Therapy Development and Operations (CTDO). 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. Supports the facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis. Required Competencies: Knowledge, Skills, and Abilities Knowledge and experience with GMP, Quality, and compliance. Ability 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. Represents department in internal and external cross‑functional teams. Contributes to goals within the work group. Ability to recognize conflict and notify management with proposed recommendations for resolution. Ability to prepare written communications and communicate problems to management with clarity and accuracy. Ability to produce data reports with precision. Ability to multi‑task. Ability to support internal and health authority inspections of facility. Education And Experience Minimum required Associate degree but prefer B.S. Degree with minimum 2 years relevant work experience. Duties And Responsibilities Supports all activities for the Label Control group. Responsible for issuing clinical and commercial in‑process and final product labels for labelling operations. Ensures 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. 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. Location and Shift 100% onsite Second Shift, Sun‑Wed 3:30 pm‑2:00 am Attendance and Operation Notes Attendance is crucial. Supporting 7 days/24 hours operations, including holidays and weekends. Contract Assignment This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to BMS. The starting hourly compensation for this assignment is $32–$34.97 per hour. Final compensation and benefits will be determined by your employer of record, ASK Staffing, Inc., and may vary based on factors such as demonstrated experience, required skill, and geographic location. ASK Consulting provides comprehensive ACA‑compliant health coverage, dental, vision, short‑ and long‑term disability for eligible employees, commuter benefits, a 401(k) plan with no matching, and a referral bonus program. Unpaid leave and paid sick leave are provided as required by law. Equal Opportunity Employer ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws. California Applicant Notice ASK Consulting is committed to complying with the California Privacy Rights Act (CPRA) effective January 1, 2023, and all relevant data privacy laws in the jurisdictions where we recruit and hire. To learn more, please review our Notice to California Job Applicants Regarding the Collection of Personal Information on our website. Applicants with disabilities may request this notice in an alternative format by contacting . Fair Chance Employment Notice As part of the Fair Chance Ordinance, we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job‑related safety, security, trust, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer. Additional Disclaimers This posting does not constitute an offer of employment. All applicants seeking positions in the United States must be legally authorized to work in the United States. Submitting intentionally false or fraudulent information may disqualify you from consideration. Any eventual offer of employment will be considered at will, regardless of the expected assignment duration. #J-18808-Ljbffr

