QA CTO Label Specialist Position Available In Union, New Jersey

QA CTO Label Specialist 4.0 4.0 out of 5 stars Summit, NJ 07901 DUTIES

AND RESPONSIBILITIES

Supports all activities for the 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 Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs Carries out plans and actions to support new drug product launches, new market and other quality management activities Provides support during internal and health authority inspections and audits of facility. Performs supplemental investigations/projects as required by Management. Maintains knowledge of current GMPs and regulatory guidelines. Responsible for supporting site Label Control activities at S-12 in accordance with policies, standards, procedures and Global cGMPs 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). 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. 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.

Qualifications:

Required Bachelor’s Degree in Science (Biology, Chemistry, etc) + minimum 2 years relevant work experience Minimum of 1 year of relevant labeling experience in a cGMP/FDA regulated environment preferred Some document management experience. Crystal reports and BarTender experience preferred. Strong communication and customer service skills. 1+ years of experience in the Biopharma 1+ years of quality experience 1+ years of labeling Experience 3+ years with MS Office 365 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. 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 Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management. This position is for 2nd shift, Sun-Wed 4:00pm-2:00am.

Benefits:

Healthcare Insurance:

Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance:

Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance:

Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k)

Plan:

The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus:

Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification. Synectics is an equal opportunity employer. #INDSYN