A Compliance Specialist II is responsible to manage the receipt, processing, monitoring and reporting of product complaints. Ensures that all product complaint investigations received are appropriately investigated and concluded per the company"s complaint handling procedure. Monitors complaint activity and provides suggestions to appropriate company authorities to modify existing processes based upon pattern and related analyses. Serves as a frequent inter-organizational contact, which will review and approve a wide variety of GMP related documents. The Compliance Specialist II interacts with key leads and/or management in all departments in conveying information and assisting in the development of solutions.

ESSENTIAL DUTIES / RESPONSIBILITIES:
Investigations Reach Sound Conclusions and CAPA"s are Identified (50%)

• Investigates product complaints to determine if complaints are valid and are indicative of the quality of product on the market. Investigations include, but are not limited to, review of batch records, retains, associated deviations/complaints and other data as identified.
• Identifies additional internal resources required for thorough investigations; works with those individuals to ensure the process is handled with the appropriate level of detail.
• Works with the appropriate discipline to identify corrective/preventative measures necessary for each observation made for improvement and to align processes to consistently manufacture quality products.
• Reviews and approves investigation reports to ensure it contains the appropriate level of detail.
• Coordinates documentation required at the completion of investigations; pulls all materials together into a concise summary that thoroughly documents the conclusions of the investigation. This could include, but is not limited to, submitting the complaint for final QA approval in the system, and assistance in preparation of a CAPA.
• Provides appropriate response to customer.

Trends Identified (25%)

• Analyzes complaints to identify trends. Prepares quarterly complaint report.
• Provides complaint reviews in support of the annual product review system, ensuring on time issuance to support publishing of APR"s within the required timeframes outlined in site procedures.

Effective & Efficient Processes (15%)

• Ensures the development, documentation and implementation of standardized processes for key business functions. Develops quantitative techniques to monitor process performance.
• Evaluates effectiveness of SOP, identifies changes that would enhance the process, and ensures that all change control documentation is implemented.
• Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Challenges the way it has always been done.
• Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance.
• Identifies the impact of available technology on business processes and ensures that it is used to maximum advantage.
• Ensures stakeholders are appropriately trained on the process and any process changes.

Guidance & Advice (10%)

• Maintains knowledge of applicable regulations and company procedures. Provides quality leadership and technical expertise on quality activities, including leading or supporting process improvement initiatives.
• Provides quality guidance to the organization for compliance issues.

REQUIRED EDUCATION:

• Bachelors" Degree Chemistry, Biology, Pharmacy, Health Science or Related Field, or equivalent experience

D. QUALIFICATIONS/EXPERIENCE:

• Minimum 5 years Quality Assurance experience in FDA regulated environment

E. SPECIFIC SKILLS:

• A comprehensive understanding of current regulatory requirements and ability to interpret them. Good teamwork and project management skills (including the ability to lead teams).
• Must be able to recognize situations where there is a potential impact on product quality, safety, identity and purity.

INDLP

Job Type: Full-time

Pay: $65,000.00 - $85,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• FDA regulations: 5 years (Required)
• Quality: 5 years (Required)

Work Location: In person