Senior Qa Associate 3Rd Shift

• Review Batch records, deviations, investigations, documents, validation protocols, and reports compliance to internal and GMP standards.
• Maintains and monitors key quality systems such as: deviations, investigations, CAPA; which includes the review of trended data to identify areas for improvement.
• Conducts system and GMP training.
• 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.
• Work directly with production, project management, and quality control to ensure that deliverables meet quality requirements.
• May directly supervise QA Associate I or QA Associate II.
• Interacts with personnel from all departments of Johnson Matthey to ensure GMP compliance.
• Recommend the stop of manufacture and/or distribution of product if necessary.
• 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.
• To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.
• Predominately in office environment. Occasional walking, standing for long periods of time while in labs/plant, kneeling, reaching, handling, twisting, and bending spine at waist when filing or operating office/lab equipment.
• Moderate travel may be necessary for technical meetings, customer visits/audits, and supplier contacts.

Qualifications

• BS in a scientific discipline or equivalent with a minimum of 7 years’ experience in an FDA regulated industry.
• MS in a scientific discipline or equivalent with a minimum of 5 years’ experience in an FDA regulated industry.
• Experience with Quality Assurance oversight and support for all phases of clinical trials.
• 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
• 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.

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