Quality Management System – Senior Specialist

Job Description

As a Senior Specialist, you will be responsible for ensuring compliance with quality standards and regulatory requirements. You will help design, modify, implement, and maintain QMS, including documentation and the auditing processes. You would also be responsible for supporting manufacturing, packaging, warehousing, laboratory operations, and others within the Quality Unit while ensuring that the product meets GMPs, are of high quality, and meet the customer requirements.

The requirements of this role include:

1. Having a minimum of five (5) years of experience in the pharmaceutical industry. Preference will be given to candidates who have experience at either generic or OTC firms. Additionally, experience in OSD is preferred [in either Manufacturing Operations (blending, compression, etc.) or Packaging Operations (bottles, blisters, cartons, etc.)]. Experience in both areas is a plus.
2. Writing and/or reviewing QMS documents (deviations, change controls, CAPAs, other quality events etc.)
3. Identifying deficiencies and proposing overall compliance improvements.
4. Possessing a high level of attention to detail
5. Knowledge of regulatory requirements.
6. The ability to work independently and collaboratively in a team environment.

Key Responsibilities:

• Initiates, investigates, and documents deviations and other quality events.
• Performs root cause analysis.
• Develops, in conjunction with area management, effective corrections, corrective actions, and preventive actions.
• Initiates, investigates, and closes customer complaints.
• Ensures customer complaint data is tracked for trend review, annual product review and management reviews.
• Assists with the Vendor Management Program including Quality Agreements
• Completes Annual Product Reviews (APRs)
• Writes and reviews documentation (quality events, standard operating procedures, work instructions, stability protocols, change controls, etc.).
• Reviews and confirms the content of artwork.
• Reviews and approves packaging specifications and master label cards (for labels and individual folding cartons)
• Completes periodic review of applicable documents within the required time limit.
• Overall responsibility for stability program. Ensures stability samples are placed on stability and evaluated according to approved protocols.
• Fulfills requests for quality documentation from customers, including maintenance of our information on customer quality portals
• Maintains and improves the level of compliance of cGMP and maintains an understanding of FDA regulatory expectations, initiatives, and requirements.
• Provides regular reports detailing the status of open quality events.

• Identifies and helps to remediate non conformances.
• Supporting the overall company GMP training program and conducting training for changes to policies and procedures
• Maintaining applicable quality databases and ensuring they are current and accurate.
• Supports ongoing quality improvement initiatives.
• Assists in maintaining an inspection readiness state.
• Supports the Director of Quality during audits and inspections

Qualifications/Education:

• BS in science required.
• Minimum five (5) years of experience in the pharmaceutical industry
• Experience working in or interfacing with pharmaceutical manufacturing, packaging, warehouse, laboratory, and quality departments.
• A thorough understanding of Quality Management Systems is required.
• Experience with an electronic QMS system is a plus.
• Experience interfacing with external vendors.
• Previous experience with customer complaints and completing APRs is required.
• Strong knowledge and understanding of GMP regulations and QMS Systems.
• Well versed with the expectations of the FDA.
• Strong interpersonal skills; ability to communicate effectively with individuals and groups; ability to communicate ideas clearly with technical and non-technical colleagues.
• Ability to manage diverse tasks and issues simultaneously through prioritization, delegation, and “hands-on” personal effort.
• Self- starter with effective interpersonal and organizational skills.
• Well versed in using MS Office
• Ability to learn new software/applications.
• Ability to write well.
• Ability to participate in a team environment with demonstration of a shared responsibility for outcomes.
• Ability to travel as needed.
• Ability to lift 25-50lbs. (relating to incoming materials, supplies.