Batch Documentation Specialist 2Nd Shift

Our Batch Documentation 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 maintaining and coordinating batch documentation for compliance with cGMP and company procedures with minimal supervision. You will review and write cGMP procedures under supervision, process changes in controlled batch records via Change Control process, issue effective documents including procedures, forms and batch records, process changes to the procedures and archive documentation to facilitate secure storage and ease of retrieval. 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 2:00 PM to 10:30 PM. 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 Batch Documentation Specialist Does Each Day:

• Issue batch records as per the production schedule; Issue logbooks

• Maintain and execute procedures for document workflow, document retention, archiving and retrieval

• Facilitate with document retrieval during audits

• Coordinate assignment of procedures effective dates with training department

• Review and write document change requests

• Interact with other departments to address required updates to procedure, forms and/or batch records

• Generate workflows for creation, revisions, review, approval and implementation of procedures, forms, logbooks, and batch records

• Ensure documents always have the most current and up to date version

• Review documents for compliance with company standards for formatting, review, approvals, and implementation

• Perform gap analysis of all quality related procedures to ensure there are no gaps present

• Act as administrator of controlled documents used for Quality functions

• Participate in process improvements and projects within the company

Our Most Successful Batch Documentation Specialists:

• Are detail-oriented with strong organizational skills

• Are independent workers, but can work in a team environment

• Have good verbal and written communications skills

Minimum Requirements for this Role:

• A High School diploma or equivalent

• Able to successfully complete a drug and background check

• At least 6 months to 1 year experience at QuVa Pharma

• 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 related field

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

• Understanding of archival process, preferred experience in document storage and controls

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

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."