2 QMS Associate Jobs in Newtown, PA
KVK TECH is Hiring a QMS Associate Near Newtown, PA
Job TitleQA Associate QMS
FLSA StatusExempt
- Role Purpose:
- Key Duties & Responsibilities:
- Conduct routine walk-throughs of manufacturing areas for adherence with SOPs and good documentation practices including but not limited to sample management and accountability, data integrity (manufacturing, calibration and maintenance logbooks, batch record documentation) and adherence with applicable safety requirements. Review documentation, results and reports from raw material and finished product analysis for accuracy and completeness.
- Perform regularly scheduled, formalized internal audits of manufacturing areas for adherence with SOPs, cGMPs, FDA, OSHA, EPA and DEA regulations.
- Review SOPs, Specifications, Batch Record Documentation.
- Maintain KPIs related to manufacturing accuracy and conformance with SOPs, regulations and Guidelines and present to the Quality Council.
- Review and maintain Quality Management Records (Change control, Deviation, CAPA, Root cause Investigations, Market complaints, Product recall, OOS and Outliers) to ensure compliance with procedures and assurance of due date requirements.
- Review validation reports for aseptic manufacturing, filling and support processes, equipment, and utilities for compliance against approved protocols.
- Ensure manufacturing compliance for adherence with aseptic technique, process validations, hold time studies, and media fill simulation studies.
- Preparation and review of Standard Operating Procedures
- Review executed documents for adherence with batch record, SOPs and protocol requirements.
- Perform quality on-floor audits, area inspections, room and line clearances.
- Assists with quality improvement initiatives as needed.
- Assists with development/ writing of SOPs or other quality documents and/or reports as needed.
- Provides consultation on quality and compliance topics in areas of expertise.
- Performs other duties as assigned.
- Complies with company polices, SOPs, and data integrity requirements.
- Typical Supervisory Responsibility:
- Education & Experience:
- Technical competencies/ Certifications/ Licenses:
- Ability to read, identify, transcribe, and communicate details accurately.
- Ability to perform daily work assignments accurately, timely and in a safe manner with moderate supervision.
- Must be able to multi-task and work in a fast-paced environment.
- Self-motivated & exceptional organizational skills.
- Ability and willingness to work cooperatively with others.
- Knowledge of Microsoft Office products (Word, Excel) .
- High degree of discretion dealing with confidential information.
- Prior experience with electronic quality systems is preferred.
- Manage time effectively to complete assignments in expected period.
- Ability to communicate effectively and follow detailed written and verbal instruction.
- Ability to train on SOPs, regulatory guidelines, and storage requirements.
- Physical demand and Work environment:
- Physical demands:
- Work environment:
Job Summary
Full Time
Pharmaceutical
$81k-99k (estimate)
05/05/2024
07/30/2024
kvktech.com
NEWTOWN, PA
200 - 500
2004
ANTHONY TABASSO
$50M - $200M
Pharmaceutical
Related Companies
About KVK TECH
KVK is a leader in the development and manufacture of high-quality, FDA-approved medicines that address unmet patient needs. We take pride in our ability to advance medical care and offer low-cost alternatives in response to todays healthcare challenges. All of our products are manufactured, packaged and distributed by KVK in the United States. VISION: By 2020, KVK will apply its relentless drive to manufacture high-quality, affordable generics in every major dosage form, states Anthony Tabasso, CEO and President of KVK Tech. And, all of our products will be made in the USA, right here in Penn...sylvania. KVK is committed to expansion through alliances across all phases of operations, which is evidenced by the current construction of a 250,000-square-foot sterile injectable plant in nearby Langhorne and the purchase of the 461,000-square-foot Lockheed-Martin complex in Newtown. We continue to explore strategic opportunities to add to our expanding portfolio and are aggressively pursuing research and development prospects, including investment in new molecular entities. And, we continue with developments in oral solids, such as extended or slow release tablets or capsules, all the while maintaining high manufacturing standards and exemplary customer service. MISSION: To continually build on our promise to deliver safe, effective and affordable FDA-approved pharmaceuticals to meet our customers needs and ensure that patients have access to high-quality medicines when they need it. Our confidence in our ability to execute and play a key role in the pharmaceutical marketplace is underscored by the dedication of our employees and their commitment to excellence in science, manufacturing, quality control, regulatory compliance and customer satisfaction.
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