Batch Documentation Specialist 1st Shift

Batch Documentation Specialist: About This Role

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 1st shift working Monday through Friday from 9:00 AM to 5:30 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
• Proficient in Microsoft Office Adobe Word and Excel

• Able and willing to walk stoop stand bend and lift up to 50 lbs. throughout each shift with or without reasonable accommodation

• 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:

• Bachelors 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
• The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience skills training education certifications geographic location and market conditions
• Salary Range: $22.00-$26.00/hour

About Quva:

Quva is a national industry-leading provider of compounded injectable medicinesand software solutions that help power the business of hospital and health-system pharmacy. Quva Pharma produces and distributes injectable medicines required by health care providers and critical to patient care. Quva BrightStreampartners with health-systems to analyze large amounts of data and through AI and machine learningdevelops softwaresolutions that turns the data into insights that are used to better run their pharmacy operation. Quvas overall product and technology offerings help health-systems achieve greater value and deliver the highest-quality patient care.

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. Quvas 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.

Required Experience:

Unclear Seniority