- Reports metrics on batch records for the site
- Works with Customer Service and Direct Distribution for placing / removing inventory holds as needed
- Reviews completed Batch Records for compliance to Regulatory and QuVa SOPs and to ensure product quality and safety standards are met
- Promptly communicates with Operations and Manufacturing Quality Assurance regarding batch record discrepancies, product issues/variances
- Escalates procedural deviations or discrepancies that have product impact to the Quality Investigations Team for review
- Reviews Variances associated with batch records for impact to the product disposition
- Reviews QC testing results, and EMPM monitoring data, are within specifications
- Enters QC testing results into Management System to generate product Certificate of Analysis (COA)
- Supports department supervision in oversight and prioritization of day-to-day responsibilities
- Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and in general compliance with cGMP
- 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
- Works to create an environment of open communication, participation, and information-sharing within and between teams within Quality Assurance and throughout facility
- Works closely with the department supervisor to ensure alignment on day-to-day priorities
- Has knowledge of sterile pharmaceutical manufacturing technologies and FDA and other applicable GMP regulations for Sterile Product
- Is detail-oriented with strong verbal and written communications skills
- Supports the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards
- Drives achievement, expresses energy, shows accountability, ability to multi-task and work in a fast-paced, quality-rich environment
- Motivates others, shares knowledge, builds high performing team, shows respect towards others, gives constructive feedback
- A High School diploma or equivalent
- Able to successfully complete a drug and background check
- At least 6 months to 1 years' experience at QuVa Pharma
- 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
- Bachelor's Degree in life science or related field preferred
- 1 to 2 years' experience in Quality Assurance, Sterile Compounding and/or GMP production facility preferred
- 1 to 2 years' experience with FDA-regulated operations (cGMP processes) preferred
- Set, full-time, consistent work schedule
- Comprehensive health and wellness benefits including medical, dental and vision
- 401k retirement program with company match
- A minimum of 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
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Lead Lot Disposition Specialist 2nd Shift - Bloomsbury, United States - QuVa Pharma
Description
Our Lead Lot Disposition 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 reviewing activities of finished good products to ensure compliance with applicable SOPs and regulatory requirements are adhered to prior to final release of product. 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 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, New Jersey location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.
What the Lead Lot Disposition Specialist Does Each Day:
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."
