Manufacturing Documentation Coordinator - Lexington, United States - Kindeva Drug Delivery

Description

Job Details

Level
Experienced

Job Location
Company Headquarters - Lexington, KY

Position Type
Full Time

Education Level
2 Year Degree

Job Category
Manufacturing

Description

Summit Biosciences is a specialized pharmaceutical company that develops, manufactures, and commercializes prescription nasal spray products. Summit Biosciences is experiencing significant growth and offers competitive compensation + annual bonus, 401k plan, paid holidays, PTO, health/dental/vision/life insurance, short/long term-disability, an incredible collaborative and challenging culture in a team-oriented environment. Second shift hours are 3:00 PM - 11:30 PM.

Summit Biosciences is an Equal Opportunity Employer. Summit Biosciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by applicable federal, state and local laws. All employment is decided on the basis of qualifications, merit, and business need.

Summary:

Responsible for coordinating all Manufacturing related documentation. Review documentation to assure it aligns with current Summit processes (Standard Operating Procedures, Batch Records, Protocols, etc.) and Good Documentation Practices (GDPs). Expertise on all Manufacturing processes and documentation.

Essential Duties:

• Review of Manufacturing logbooks, Production Batch Records (PBRs), and Forms to ensure compliance to SOPs and GDPs and allow for timely release of product
• Review Manufacturing executed protocols and reports to ensure adherence to SOPs and GDPs
• Organize current and archived Manufacturing documentation to assure accessibility of the documents when required. Assist with training of Manufacturing employees on GDPs. Assist with Manufacturing operations as needed
• Create tracking systems to maintain control of Manufacturing documentation
• Write and revise SOPs and Forms to accurately reflect the current procedures
• Stay current on pharmaceutical industry documentation practices
• Assist in developing and managing documentation related to the change control and change tracking system
• Coordinate with multiple departments to complete incident reports, deviations, work requests, engineering change requests, corrective actions and preventive actions, and protocols
• Preparation of quality metrics related to document execution
• Adhere to cGMPs, SOPs, and Safety policies
• Other duties as required

Candidate Attributes:

• Excellent organizational skills and attention to detail
• Strong interpersonal and communication skills
• Experience in a cGMP manufacturing environment
• Self-starting and ability to multitask
• Ability to change priorities in response to company demands while continuing to deliver results
• Enthusiasm for building a company with outstanding work ethic; must be able to excel in a fast-paced, multiproduct environment
• Enthusiasm for working in teams and collaborating with internal colleagues
• Experience with Microsoft Word, PowerPoint, and Excel

Qualifications

• 1+ years of applicable experience working in a pharmaceutical manufacturing environment
• Excellent written communication skills for creating SOPs and other cGMP documents
• Qualified to work with controlled substances
• B.S. Degree in a scientific field is preferred
• Strong interpersonal skills and the ability to work well in a team environment