24 days ago
Quality Assurance Specialist
Job Id: 10823
Are you looking to make a career change to a rapidly growing and innovative organization? This exciting opportunity offers a competitive salary plus an excellent benefits package including Medical, Dental, and Vision insurance and Paid Time Off. Does this position match your future career goals? Then this opportunity could be the right fit for you.
- Ideal candidates should have good leadership skills and should be able to supervise environmental sampling/testing /reports, manufacturing, packaging, labels, material approval, and review of investigations. Review quarterly reports, annual summary reports and biannual historical reports.
- Analyze and approve documents supporting manufacturing and development operations, including QAPs, SOPs, pre- and post-executed batch records, and deviation reports. Document Control experience is required.
- Managing the Master Batch Record, pre and executed review/audit and approval.
- Prepare, review the execution of process validation and equipment qualification protocols.
- Analyze and approve use of a Master Label and controlled labels; issue and reconcile and destroy controlled labels.
- Update Quality Systems such as tracking deviations, corrective, and preventive actions, change controls, receipt of materials, audit commitments, and other essential quality indicators.
- Guide in implementation and effectiveness of new and improved Quality Systems.
- Supervise GMP training, QA support for the site, when required.
- QA supervisory functions such as approving time sheets, training schedules, and time off approvals as well as supervise internal and external audits such as document and manage investigations, inconsistency, technical issues, complaints, and non-compliances, record and review vendor qualification program.
- Able to review and streamline SOP’s, policies, and processes to ensure quality checks follow cGMP standards, FDA and all competent authority regulations and requirements.
- Excellent communication skills as they should act as SPOC for client and regulatory audits.
- Bachelor’s degree in Science (BS/BA) from a four-year college or university preferred; or five (5) to seven (7) years pharmaceutical or related experience and training; or equivalent combination of education and experience.
- Well versed in aseptic processing and technology, including US compliance and regulatory requirements, and working knowledge of EU requirements desired. Experience in implementing cGMPs, FDA & DEA, US and EU Regulations.
- Proficient in Microsoft Office Products, including standard MS Office Suite applications and Adobe Acrobat. Document management software knowledge is preferred.
- Leadership experience preferred.
- Effective oral and written communication skills.
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Direct Hire
Ask for: Trisha Moitra
Ajulia Executive Search is a New Jersey based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements.