Quality Assurance Associate I

Company Description

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.

Job Description

Perform review and release of Active Pharmaceutical Ingredients (APIs) in support of clinical and commercial product manufacturing. Assist in the development, implementation, and maintenance of quality systems and other Quality Assurance activities. Determine new methods and procedures for new assignments and provide guidance to lower-level Quality Assurance personnel.

Key Responsibilities / Accountabilities

• Review Batch records, deviations, investigations, documents, validation protocols, and reports compliance to internal and GMP standards.
• Maintain and monitor key quality systems such as: deviations, investigations, CAPAs; which include the review of trended data to identify areas for improvement.
• Represent the department during client audits and FDA inspections, if needed.
• Write and revise Standard Operating Procedures (SOPs) as required.
• Provides guidance and training for other Quality Assurance staff in the accomplishment of Quality Assurance operation activities.
• Interact with Veranova colleagues from all departments to ensure GMP compliance. Conduct system and GMP training.
• Review Master documents such as In-process forms and Batch Records.
• Approve stability study protocols, validation documents, test methods, and reference standards.
• Interact with contractor personnel regarding validation and qualification activities.
• Assist in the scheduling and maintenance of Quality Assurance activities and systems.
• May required carrying out other duties which are within the employee’s skills and abilities whenever reasonably instructed.

Qualifications

• Must have a minimum of a High School diploma and experience in an FDA regulated industry in a pharmaceutical, medical, or quality field.
  • With High School Diploma or equivalent, must have a minimum of 5 years of experience in an FDA regulated industry in a pharmaceutical, medical, or quality.
  • With associate degree in a scientific discipline or equivalent, must have a minimum of 2-5 equivalent work experience in an FDA regulated industry in a pharmaceutical, medical, or quality.
  • With BS degree must have a minimum of 1-3 years’ work experience in an FDA regulated industry in a pharmaceutical, medical, or quality.
• Experience with Quality Assurance oversight and support for all phases of clinical trials is required.
• Must be able to demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations.
• Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11.
• Good understanding in one or more of the following areas: Quality systems, Analytical, Regulatory, Qualifications, Environmental monitoring, Vendor management.
• Expertise in FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals.
• Experience mentoring and training staff members in a Quality department.
• Experience with Microsoft Office and other complex computer software
• Experience with commercial phase pharmaceuticals and EMEA experience.
• Demonstrate attention-to-detail, problem solving, and ability to make decisions quickly.
• Excellent analytical, written, and verbal communication and presentation skills.
• Strong technical writing skills and the ability to clearly express ideas in English.
• Ability to work independently and in a team environment
• Ability to positively resolve conflict
• Flexibility for changes in work priorities

Additional Information

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.