QA Batch Record Associate

Description :

• Responsible for life cycle management of issued labels and documentation as well as the timely and effective GMP review of production records.
• MES / SAP / LIMS Super User to include floor support and training.
• SPOC for Batch Record Process includes creating reports; production terminating and approving records; issue resolution.
• Reviews all batch documentation for accuracy and completeness according to cGMP's to ensure timely release.
• Ensures deviations are initiated for any batch record review related events Find / communicate deviations to QA / help with investigation
• Adheres to internal / external guidelines, specifications and regulatory requirements while reviewing batch documentation.
• Ensures all GMP's, Work Procedures and SOP's are followed.
• Positively interacts with internal associates to quickly and effectively resolve batch record documentation related issues.
• Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all batch review issues according to GMP standards and objectives.
• Within MES, is responsible for TECO all Manufacturing orders.
• Provide periodic updates at Manufacturing Team meetings to review current batch record errors to improve performance.
• Maintains strong collaborative relations with the Quality Group
• Maintain and follow CGTDM procedures for MBR creation, issuance, receipt, reconciliation, filing and archiving
• Print and issue batch records, in-process labels, and final product labels to support operations.
• Issue labeling / tags for Apheresis through packaging of final product labelling to QA / Operations.

Qualifications :

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.