Incoming Quality Assurance Specialist 2Nd Shift

Our Incoming Quality Assurance Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include coordinating Incoming Quality Assurance (IQA) aspects of raw materials and sterile supplies for compounding pharmaceuticals as well as perform preprinted label receipt inspections and quality processes. This role requires critical thinking and authority to proactively address and/or escalate IQA issues. The Incoming Quality Assurance Specialist performs basic QA functions related to verification of incoming materials Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

This is a full-time role for our 2nd shift, working Monday through Friday from 2:00pm to 10:30pm. This is a set, consistent schedule with minimum overtime requirements and based on site in our Bloomsbury, NJ location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.

What Incoming Quality Assurance Specialist Each Day:

• Disposition steps in ERP system; Assess critical data on released items in ERP system

• Release/Disposition of raw materials, sterile supplies, and labels

• Inspection of bulk bags from other QuVa sites

• Assist with the Coordination of transfers between QuVa Sites

• Incoming Environmental plate sampling or sending for testing

• Quality inspection and disposition in ERP of labels

• Manages In Process QC Supplier Ready for Receiver reports

• Quality inspections verification raw materials, sterile supplies

• Initiate DMI/DMR of non-conforming material

• Quality review / verification of critical information related to the receipt of incoming materials

• Escalate any discrepancies or non-conformances found during incoming receipt inspection

• Retrieves / requests quality documents (CoA, CoC, CoS...) from vendors for incoming materials

• Ensures compliance of incoming materials prior to use in Manufacturing Operations

• Ensures company compliance to QuVa Pharma's Standard Operating Procedures (SOPs) and Quality Management System (QMS)

• Follows all regulatory guidelines, cGMP guidelines as required by the job function

• Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMPs

Our Most Successful Incoming Quality Assurance Specialist:

• Have strong technical writing and verbal/written communication skills

• Develop action plans to meet a specific objective including identification and methods of tasks, milestones, resources requirements and metrics

• Possess time management skills

Minimum Requirements for this Role:

• A High School diploma or equivalent

• Able to successfully complete a drug and background check

• At least 2 years' experience in FDA regulated Quality Assurance, Sterile Compounding and/or GMP production facility

• Understanding in updating Standard Operating Procedure, with documentation of summary of changes and version control

• Proficient in Microsoft Office, Adobe, Word and Excel

• Must be currently authorized to work in the United States on a full-time basis; QuVa is not able to sponsor applicants for work visas

Any of the Following Will Give You an Edge:

• Bachelor's Degree in life science or equivalent work experience
• 2 years' QuVa Pharma Quality Assurance Technician

Benefits of Working at QuVa:

• Comprehensive health and wellness benefits including medical, dental and vision

• 401k retirement program with company match

• 17 paid days off plus 8 paid holidays per year

• National, industry-leading high growth company with future career advancement opportunities

About QuVa:

QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide. As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.

As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.

QuVa is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. QuVa's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with QuVa is "at will."