Senior QA Associate at Veranova L P

Devens, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Oct, 26

Salary

105000.0

Posted On

17 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, cGMP, ICH Q7, ALCOA+, Batch Disposition, Lot Release, FDA Regulations, 21 CFR Part 11, Deviation Management, CAPA, Audit Representation, Technical Writing, Mentoring, Quality Control, API Manufacturing, Compliance Monitoring

Industry

Pharmaceutical Manufacturing

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 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. Every role at Veranova plays a part in delivering an exceptional customer experience through ownership and integrity. Role Overview: This position is responsible for monitoring the day-to-day use of established control procedures to ensure compliance of manufacturing and testing activities within the Pharmaceutical Materials unit with the requirements of the applicable laws and regulations of the countries/regions where Veranova products are marketed, (i.e. USA and European Union) and Veranova internal procedures/policies/SOPs. Core Responsibilities: * Support Manufacturing and Quality Control operations on and off the floor, by proving QA support to operations in compliance with cGMP, ICH and ALCOA+ principals. * Review of Executed Master Batch Records and provide documentation guidance both on the floor and off the floor for completeness, compliance and accuracy to support lot disposition. * Perform Batch Disposition and Lot Release activities. * Support issuance activities for Master Batch Records and other records, as needed. * Provide final authorization for new controlled documents, such as master batch records and packaging master records. * Exercise independent judgment utilizing generally defined practices and policies to make sound, logical decisions and propose effective solutions to complex problems. * Ensure on-time disposition and delivery of all raw materials, in-process and finished drug substances. * Analyze systems and propose system quality improvements as needed. * Provide final authorization to production of batch records to begin processing and review and final close out of completed batch records. * Ensure that all test results meet established specifications before either raw material, in-process materials or finished drug substances are "released". * Develop, review, approve and maintain all documentation required to support effective QA/QC procedures and audits. * Provide final authorization for new controlled documents, such as master batch records and packaging master records. * Ensure proper training of all production operators and technicians on existing, new and revised policies and procedures. * Conduct cGMP training sessions based on trend analysis and audit findings as required. * Perform GMP Walkthroughs for all areas of the site per procedure. * Review of quality event records pertaining to deviations, investigations, CAPAs, CRMs and Customer Complaints. * Represent the department during client audits and FDA inspections. * To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed. Qualifications: * BS in a scientific discipline or equivalent with a minimum of 5-7 years’ experience in an FDA regulated industry OR MS in a scientific discipline or equivalent with a minimum of 3-5 years’ experience in an FDA regulated industry. * Experience with Quality Assurance oversight and support for all phases of clinical trials. * Experience with supporting On the Floor Walkthroughs of Manufacturing areas. * Experience with Active Pharmaceutical Ingredients (APIs) and commercial phase pharmaceuticals. * Experience working with Clients, direct facing and email communications * Knowledge and previous experience with GMP, FDA regulations, ICH Q7, 21 CFR Part 11. * Good understanding in one or more of the following areas: Quality systems, Analytical, Manufacturing * Experience mentoring and training staff members in a Quality department. The salary range for this role is $90,000-105,000. This range represents a good-faith estimate of the compensation we expect to offer for this position at the time of posting. Actual compensation will be based on factors such as relevant experience, skills, qualifications, and internal equity. In exceptional cases, compensation may exceed the stated range. All full-time employees are eligible to participate in our annual incentive bonus program. Bonus targets vary by career level and are based on individual and company performance. Our Commitment: · Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. · Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs. · 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 welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don’t meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team. 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 a 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. [https://veranova.com/recruitmentscamswarning/] * 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). If you have any doubts or concerns about the authenticity of a job posting, please reach out to our HR department: pharm.hr@veranova.com (US. 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 [https://veranova.com/privacy-policy/].

Responsibilities

Responsible for monitoring day-to-day control procedures to ensure manufacturing and testing compliance with FDA and EU regulations. Key duties include reviewing batch records, performing lot release, and managing quality events like deviations and CAPAs.