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Form of workJob Description
Description:
- Responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance to current GMP regulations, procedures and quality systems.
- Perform release of all manufactured, packaged and tested materials including but not limited to raw materials, intermediates and drug products.
- Confirm all documentation supporting these releases fully adhere to cGMP, including data integrity.
- Ensure timely escalation to management of all applicable incidents.
- Controlled issuance of batch records in preparation for manufacturing.
- Perform review of manufacturing batch records in preparation for Batch Release and escalate any discrepancies immediately.
- Assist functional areas with achieving timely and compliant final product disposition of the product.
- Ensure Specifications in place and are within GMP compliance.
- Support metric tracking of documentation and release data to ensure continuous improvement.
- Support QA Batch Release as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
- CAPA management as well as improving processes within QA Batch release.
- Organize and file all executed and associated GMP documentation (e.g. batch records).
- Maintain batch documentation library (record check-in, check-out, follow-up, and distribution).
Qualifications:
- Bachelor's Degree, preferably in Life Sciences, chemistry, or related relevant degree.
- 5+ years of experience in a GxP Biopharmaceutical manufacturing operations.
- 4+ years of experience in a quality assurance role.
- Cross functional collaboration skills
- Functional Breadth.
- QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring and cleanliness zones is desired.
- Proven track record and practical experience with cGMP requirements.
- Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
- Competencies
- Continuous Learning (Dyn. Knowledge Development).
- Digital and Technology Savvy.
- Operational Excellence.
- Being Resilient.
- Breakthrough Analysis.
- Interpersonal Savvy.
- Organizational Savvy.
- Technical / Function Skills:
- Knowledge of GMP and regulations, including FDA regulations (21 CFR Parts 211, 212) and ICH.
- Knowledge of IT Applications and tools.
- Quality Assurance.
- Quality Control (QC) Testing.
- Quality Standards.
- Sterility Assurance and Aseptic Manufacturing.
- Quality oriented with attention to details.
- Time management skills.
- Developed management and communication skills.
Synectics is one of the nation's foremost consulting firms, working with a client base that includes some of the leading institutions and Fortune 500 corporations in the United States. We seek to bring the most highly qualified professionals to assignments that they will find challenging and fulfilling. We also seek to justify our clients’ expectations that every Synectics consultant will bring the highest possible effort to their endeavors every day. Our success has depended on our consistent ability to achieve both of these goals.
Synectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions. The technologies we support have always been responsive to this extremely broad spectrum. In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds. This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.
Synectics is an Equal Opportunity Employer.
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.
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 serves an extremely diverse client base which represents an equally diverse range of industries and institutions. The technologies we support have always been responsive to this extremely broad spectrum. In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds. This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.
Synectics is an Equal Opportunity Employer.
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.
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.
