Sr. Quality Assurance Specialist

A brief overview

The Sr. Quality Assurance Specialist fulfills a critical role in Quality Assurance. This individual will contribute an advanced level of understanding of GMP system improvements, technical documents, and review of GMP documentation and reports. This individual must also provide GMP and related guidance, data analysis, and technical review of QC data. in some instances, this role may act as the deputy for the Manager, Quality Assurance.

What you will do

• Perform all duties pertaining to a QA specialist I, II, III, in addition to those listed below.
• Support real time batch record review in a timely manner and with high accuracy, performing usage decisions in electronic batch release systems.
• Suggest and implement improvements in quality systems and SOPs taking into account LEAN GMP approaches.
• Reviewing and approval of all GMP documentation, which includes BPRs, validation protocols, data, reports, etc.
• Reviewing, analyzing, and trending data to extract relevant information.
• Work closely with other functions and sites to close out quality records, investigations e.g., OOS, and approval of documents and changes e.g., MBPRs, analytical procedures, protocols, reports, and specifications/global specifications.
• Suggests/recommends and implements new policies and procedures to improve existing processes and products.
• Problem resolutions with GMP systems as well as guiding on GMP topics.
• Be an active part in increasing the quality culture in the organization e.g., by guidance and training of other departments and sites.
• Perform GMP audits for internal operations, GMP compliance improvements and provide GMP compliance guidance to other departments and BAM Sites as needed.
• Support actively and able to take the lead in customer/authority audits. Writing new and revising current standard operating procedures (SOPs), specifications, etc. In addition, provide technical assistance on production and quality systems documents.

Qualifications

• Bachelor's Degree in organic chemistry or related field required or
• Master's Degree in organic chemistry or related field preferred
• Bachelor's Degree in a science related field and a minimum of 5 years' experience in a GMP manufacturing setting required or
• Associate's Degree in a science related field and a minimum of 7 years' experience in a GMP manufacturing setting required
• 4-6 years experience in Quality Assurance required
• 4-6 years experience with GMP document control, validation, qualification and calibration preferred
• 4-6 years Ability to work in ISO7 and ISO8 control environment and support real time batch record review required
• 4-6 years experience in internal auditing as well as working with regulatory agencies preferred
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to effectively organize, multitask and work in fast-paced, deadline driven work environment.
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
• Detail oriented with the ability to troubleshoot and resolve problems.
• Ability to work independently and manage one's time.
• Communicate effectively and ability to function well in a team environment.
• Certified Quality Process Analyst - ASQ preferred or
• CQA preferred or
• CQE certification desired preferred