Documentation Specialist - DPI

The job duties for this position include but are not limited to the following: 

• Works with Manufacturing/Packaging to deliver timely batch record review across all shifts.  

• Reviews and approval of master batch records. 

• Develops appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets. Generates and reports on metrics on agreed frequency 

• Creates training materials for subject matter input. 

• Track and manage periodic review of approved procedures. 

• Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory guidance. 

• Provides data to support management evaluation of performance trends. 

• Owns quality records (change control, CAPA’s, deviations) and delivers to established timelines. 

• Autonomously leads and manages projects to implement continuous improvement opportunities. 

• Lead and/or support root cause investigations related to performance trends and formal deviations. 

• Develop, implement and assess solutions for complex problems. 

• Anticipates risk and builds contingencies to help mitigate impact. 

• Reviews document for accuracy and completeness. 

• Defends the validation programs and strategies to customers and regulatory auditors. 

• Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols.  

• Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment. 

• Performs other duties as assigned. 

Education and Experience 

• Associate degree with 1-3 years knowledge and experience of GMP documentation required. 

• Bachelor’s degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or related discipline from an accredited college/university preferred. 

• Master’s degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university preferred. 

• Minimum one (1) year documentation experience and three (3) years related pharmaceutical or biotech industry experience. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.   

• Here’s a cleaned‑up, streamlined version that removes redundancy, tightens language, and groups related requirements while keeping the original intent and scope. This is suitable for an HR‑ready job description. 

Technical Knowledge and Computer Systems Skills 

• Proficient in Microsoft Office Suite, with intermediate skills in Word and Excel. 

• Strong organizational and time‑management skills with the ability to prioritize multiple tasks in alignment with departmental and site‑wide objectives. 

• Ability to work independently as a self‑starter and collaboratively within a dynamic, cross‑functional, team‑based environment. 

• Demonstrated attention to detail, strong analytical skills, and solid basic math proficiency. 

• Ability to read, write, and communicate effectively in English. 

• Flexible and adaptable, with the ability to thrive in a fast‑paced manufacturing environment and adjust quickly to changing priorities and schedules. 

GMP, Compliance, and Quality Systems Knowledge 

• Working knowledge of pharmaceutical manufacturing operations and associated documentation. 

• Knowledge and hands‑on experience with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and strict adherence to internal protocols and Standard Operating Procedures (SOPs). 

• Experience writing, revising, and creating cGMP records, SOPs, batch records (BMR/eBMR), eLogbooks, and documentation templates. 

• Knowledge and handling of deviations, CAPAs, change controls, FMECA, OOS, OOT, training records, and OOAC. 

• Experience supporting compliance activities, including participation in local and federal regulatory audits. 

• Ability to facilitate problem solving and root cause investigations, and to develop, implement, and assess solutions to complex issues. 

• Responsible for closure of compliance‑related CAPAs. 

Systems, Data, and Planning 

• Experience with electronic quality and document management systems such as SAP, MasterControl, and TrackWise preferred. 

• Ability to understand, analyze, and interpret complex data sets; experience with statistical analysis tools is a plus. 

• Knowledge of batch planning and execution in accordance with production plans. 

• Experience with dry products (DPI) is a plus.