Job Description

Perform QC review of Active Pharmaceutical Ingredients (APIs) in support of clinical and commercial product manufacturing of in-process, release and stability to the highest standards with a strong Empower/LIMS understanding. Perform deviations, investigations, OOS, documents, change controls, corrective/preventative actions and complaints to the highest GMP standards. Assist in the development, implementation, and maintenance of quality systems and other Quality Control activities.

· Perform QC review of chemical testing of raw materials, intermediates, and Active Pharmaceutical Ingredients (APIs) in support of process research, discovery research, reference standard, GMP production, and stability testing with a strong ability in Empower and LIMS

· Write QC deviations, investigations, OOS, change controls, corrective/preventative actions and complaints to internal and GMP standards. Assist in the development, implementation, and maintenance of quality systems and other Quality Control activities.

· 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 Quality Control staff in the accomplishment of Quality Control operation activities including GMP/GLP.

· Develops efficient and timely project objectives. Detect and evaluate problems with analytical processes and contribute in developing methods and techniques for solutions to those problems.

· Prepare scientific reports and documents.

· Interact with internal and external clients.

· Compose Standard Operating Procedures (SOPs) and GMP documents.

· Provide technical advice to team members, and other Johnson Matthey Pharma Services (JMPS) departments.

· Develop technical proficiency, think independently, exercise sound judgments that correspond with experience, and adhere to safe work practices.

· To take on any other duties which are within the employee’s skills and abilities whenever reasonably instructed.

Qualifications

· BS in Analytical Chemistry or equivalent with 5-7 years related experience in a pharmaceutical industry.

· MS in Analytical Chemistry or equivalent with 3-5 years related experience in a pharmaceutical industry.

· Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations.

· Demonstrate attention-to-detail, good judgment, problem solving, and ability to make decisions quickly.

· Excellent analytical, written and verbal communication and presentation skills.

· Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11.

· Expertise in FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals. Experience mentoring and training staff members in a Quality department.

· Ability to work independently and in a team environment

· Ability to positively resolve conflict

· Experience with Microsoft Office, Empower and LIMS, statistical software and another complex computer software

· Flexibility for changes in work priorities

· Ability to read, analyze, and interpret English-language chemical periodicals, scientific journals, and regulatory documents.

· Experience communicating effectively to management.

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.