QA Associate, Document Control

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.

The QA Document Control Specialist position issues, collects, maintains and distributes all documents necessary to control manufacturing and laboratory processes that ensure conformance to customer requirements; develops and maintains a comprehensive filing system and computer database for all documents to be retained in the document control center; manages the operation of the document control center to ensure that all records are maintained in an orderly fashion and ensures fast retrieval of documents.

Responsible for assisting in the execution of departmental objectives.

• Ensure compliance with all relevant laws and regulations as well as Veranova procedures, policies, and SOPs. The incumbent has first line responsibility for assuring that on a day-to-day basis, established procedures are followed by production and laboratory personnel.
• Upon request of the department, it issues appropriate batch records to start process of batches and logbooks.
• Maintain a computer database of all filed documentation
• Performs inspections for shipped API’s
• Reviews all completed documents Batch record, raw material, QC data packets and Shipping/Receiving records to verify that all pages are completely filled out and compliant with GMP Regulations.
• Scans, files and archives completed GMP records.
• Organizes and maintains paper, electronic and off-site document storage files for quick, efficient retrieval.
• Maintain communication with production/logistics/quality control to ensure that their needs are met with any documents they may need throughout the day.
• Controls documents being shipped and retrieved to different departments both on and off-site from document storage facility.
• May conduct internal audits
• Issue batch and cleaning records to production for processing and audit executed records
• Accurately maintain document control databases as necessary
• Provide support to Quality Assurance during regulatory agency audits
• Print, review and reconcile shipping labels as required
• Provides support to various programs, i.e. environmental monitoring, retains, pest control, annual gas qualification, water monitoring

• Bachelor’s degree in chemistry, chemical engineering, quality or related discipline
• 1-3 years of experience in API manufacturing in an FDA/DEA regulated environment
• Proficiency in Microsoft Word, Excel, Outlook, Adobe Pro.
• Ability to exercise sound discretionary judgment prioritizes multiple competing tasks, and work with some supervision.
• Strong interpersonal skills
• Ability to communicate effectively with all departments.
• Incumbent must be able to sit at a computer and to use a computer keyboard for long periods of time.

• Health & Wellness:
  Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
• Financial Wellness:
  Comprehensive total compensation package that includes competitive base salary, Defined Contribution Pension program, eligibility for performance-based bonuses, and attractive 401(k) Plan with company match.
• Professional Development:
  Opportunities for continuous learning through Linked In Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
• Inclusive Culture:
  At Veranova an inclusive culture is integral…