Quality Record Review Specialist 1St Shift

Our Quality Record Review 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 providing daily on-the-floor support and oversight of all aspects regarding documentation of compounding pharmaceuticals. 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 6:30am to 2:30pm. 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 the Quality Record Review Specialist Does Each Day:

• Perform timely and accurate review and completion of finished product and intermediate batch records to assure each batch meets quality standards and specification prior to release

• Assure QA records including but not limited to Batch Records, Logbooks and all other relevant records are correct and complete

• Work closely with Operations to promote awareness on Good Documentation Practices and Data Integrity

• Navigate through various systems such as Master Control, LMS, and INFOR

• Supports real-time oversight to the Manufacturing unit to ensure that all products produced meet formulation, compounding, labeling, and packaging requirements

• Supports failure and discrepancy investigations and documenting investigations on process deviations or equipment malfunctions

• Supports to identification and implementation of appropriate corrective actions and preventive actions

• Supports QA support during aseptic processing

• Supports Environmental Monitoring within an aseptic environment

Our Most Successful Quality Record Review Specialist:

• Detail-oriented with strong verbal and written communications skills

• Expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environment

• Fulfills expectations, establishes sustainable relationships with team members, maintains effective and meaningful communication channels

• Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals

Minimum Requirements for this Role:

• 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

• Able to successfully complete a drug and background check

• High school Diploma or GED from recognized institution or organization

• Familiarity with and comfortable using mobile devices such as smartphones, tablets, handhelds

• 18+ years of age

• 2 years' experience in Quality Assurance / cGMP / FDA regulated industry

Any of the Following Will Give You an Edge:

• Bachelor's Degree in Life Science or another related field

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

• Occasional weekend and overtime opportunities with advance notice

• 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."