Sr. Quality Assurance Specialist

About the role

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.

Responsibilities

• Perform all duties pertaining to a QA specialist I, II, III.
• 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.
• Review and approve all GMP documentation, which includes BPRs, validation protocols, data, reports, etc.
• Review, analyze, and trend 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).
• Suggest and implement new policies and procedures to improve existing processes and products.
• Resolve problems with GMP systems and provide guidance on GMP topics.
• Increase quality culture in the organization through 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 and take the lead in customer/authority audits.
• Write new and revise current standard operating procedures (SOPs), specifications, etc., and 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, or
• 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 of experience in Quality Assurance required.
• 4–6 years of experience with GMP document control, validation, qualification, and calibration preferred.
• 4–6 years of ability to work in ISO 7 and ISO 8 control environments and support real-time batch record review required.
• 4–6 years of 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 a fast-paced, deadline-driven work environment.
• Ability to communicate proactively and in a 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.
• Ability to communicate effectively and function well in a team environment.
• Certified Quality Process Analyst (ASQ) preferred, or CQA preferred, or CQE certification desired.

Pay

Annual Salary Range: $97,174.20 – $133,614.80. Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Benefits

• Annual performance bonus
• Comprehensive Medical/Dental/Vision coverage
• 401(k) plan with employer contribution
• Paid vacation, personal, and sick days