Sterility Assurance Specialist 1st shift

Socket.dev; Bloomsbury (NJ); On-site; USD 54,068,000 - 78,340,000; Full time

Benefits offered by this job

Health benefits and wellness

401k retirement program with company 


17 paid days off + 8 holidays

Job summary

Quva Pharma seeks a Sterility Assurance Specialist to oversee QA aspects of sterility assurance, including EM/PM monitoring. You will ensure SOP/QMS compliance, train personnel, and support investigations from a facility in Bloomsbury, NJ.

A set 1st shift schedule applies, with drug testing and background checks per policy. This full-time role requires knowledge of sterile manufacturing and FDA GMPs, plus the ability to work in a fast-paced environment while maintaining precise attention to

Qualifications

• High School diploma or equivalent is required.
• Able to pass drug and background check.
• Strong Microsoft Word and Excel skills.
• Authorized to work in the United States on a full-time basis; no visa sponsorship.
• Knowledge of sterile pharmaceutical manufacturing technologies and FDA GMP regulations for sterile products.

Responsibilities

• Ensure compliance to SOPs and QMS.
• Schedule & Proctor Media Fills.
• Read and account for EM/PM plates and environmental monitoring.
• Maintain EM/PM records and review data for trends.
• Provide aseptic technique and gowning training support.
• Support sterility investigations and deviations.
• Ensure adherence to cGMPs in the area.

Skills

Microsoft Word

Microsoft Excel

Education

High School diploma or equivalent

Bachelor's Degree in life science or related field

Job description

Our Sterility 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 the oversight and performance of the Quality Assurance aspects of Sterility Assurance, including Environmental/Personnel Monitoring teams to ensure compliance within the facility. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. 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 1st shift, working Monday through Friday from 6:00am to 2:30pm. This is a set, consistent schedule 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 the Sterility Assurance Specialist Does Each Day:

• Ensures company compliance to Quva Pharma's Standard Operating Procedures (SOPs) and Quality Management System (QMS)
• Schedule & Proctor Media Fills
• Performs reading of media aseptic process simulations and Environmental/Personnel Monitoring (EM/PM) plates and accounting of all units
• Performs EM/PM sampling; Maintains EM/PM records
• Periodically reviews Environmental/Personnel monitoring data to identify any potential trends
• Providing training support for personnel on appropriate aseptic techniques and gowning techniques including execution of Compounder Competency Assessments
• Provides support for sterility investigations including EM/PM excursions and review of deviations and investigations
• Works in accordance with area Supervision to provide quality assurance oversight where the business is responsible for adhering to current Good Manufacturing Practices (cGMPs)
• Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes
• Provides an established technical expertise for current processes and oversees training of department personnel on new processes
• Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products
• Evaluation of batches / product for compliance with defined specifications
• Sampling, inspection, and control of commercial product labels
• Review and approval of shipping documentation for commercial products

Our Most Successful Sterility Assurance Specialists:

• Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility
• Are detail-oriented with strong verbal and written communications skills
• Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards
• Act decisively with purposeful pursuit of goals or objectives, and thinks strategically in terms of solutions
• Drive achievement, expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environment
• Motivate others, share knowledge, build high performing teams, show respect towards others, and give constructive feedback

Minimum Requirements for this Role:

• A High School diploma or equivalent
• Able to successfully complete a drug and background check
• Strong Microsoft Word and Excel skills
• 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
• Knowledge of sterile pharmaceutical manufacturing technologies and FDA and other applicable GMP regulations for Sterile Product

Any of the Following Will Give You an Edge:

• Bachelor's Degree in life science or related field
• At least 1 year experience at Quva Pharma
• At least 2 years' experience in Quality Assurance, Sterile Compounding and/or GMP production facility
• At least 2 years' experience with FDA-regulated operations (cGMP processes)

Benefits of Working at Quva:

• Set, full-time, consistent work schedule
• 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
• Pay range $18.85- $27.34 based on experience

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."

California Consumer Privacy Act (CCPA) Notice for Applicants and Employees