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Quality Assurance Document Control Specialist

Veranova L P
locationWorcester County, MA, USA
PublishedPublished: 6/14/2022
Technology
Full Time

Job Description

Job Description

Discover Veranova

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focuses 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.

Role Overview:

We are seeking a Quality Assurance (QA) Document Control Specialist to manage the issuance, collection, and maintenance of critical manufacturing and laboratory documentation to ensure compliance with customer and regulatory requirements. This role plays a key part in organizing and maintaining a comprehensive document control system for efficient access and retrieval. It’s an excellent opportunity for a detail-oriented individual to support quality operations in a fast-paced, GMP-regulated environment.

Core Responsibilities:

  • 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, issues appropriate batch records to start process of batches and logbooks.
  • Maintain a computer database of all filed documentation.
  • Oversees retain program inventory.
  • 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.
  • May review environmental monitoring reports.

Qualifications:

Required

  • High school diploma or general education diploma (GED) or 3-5 years of related experience.
  • 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.

Our Commitment:

  • 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 LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
  • Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.

How to Apply:

At Veranova, we are on a misson to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit www.veranova.com to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise.

We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed.

For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to talentacquisition@veranova.com in order to confirm your request for an accommodation. Please include the job number, title, and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Additional Information:

Applicants for this role must be authorized to work in the United States without further employer sponsorship.

Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.

Important Notice Regarding Recruitment Scams: Veranova is committed to providing professional and secure recruitment experience for all applicants. Unfortunately, fraudulent job postings and recruitment scams are becoming more prevalent. We want to ensure that all candidates are aware of potential scams. Please see our notice here.

  • Legitimate communications from Veranova will only come from official email addresses using our domain: veranova.com.
  • Legitimate LinkedIn communications will only come from active Veranova employees.
  • Veranova will never ask candidates for sensitive personal information during the application process (e.g., bank account details or social security number).
  • Veranova will never ask candidates for payment (e.g., for equipment, training, or background checks).

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

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