PKG. Documentation Specialist II

Job Title: Pkg. Documentation Specialist II

FLSA Classification: Professional, Exempt

Work Location: Fall River, MA

Work Hours: General Shift: 8:30AM - 5:00PM (may vary based on business needs)

Reports To: Department Head - Manufacturing

Salary Range: $72,800 - $93,600

Invagen Pharmaceuticals is searching for experienced candidates for the position of Documentation Specialist. The Documentation Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as SOPs. In this role the Documentation Specialist adheres to the company's document and SOP procedures while ensuring their accuracy, quality, and integrity. This position reports to the Department Head - Manufacturing and partners with cross‑functional team members to ensure compliance and operational success through user‑focused documentation at Inva Gen Pharmaceuticals, Inc.,

Fall River, MA.

• Works with Manufacturing/Packaging to deliver timely batch record review across all shifts.
• Reviews and approves master batch records.
• Develops appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets. Generates and reports on metrics on an 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, CAPAs, 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 documents 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 current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment.
• Performs other duties as assigned.

• Associate degree with 4–6 years knowledge and experience of GMP documentation required.
• Bachelor's degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or a related discipline from an accredited college/university.
• Master's degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or a related field of study from an accredited college/university preferred.
• Minimum two (2) years documentation experience and four (4) years related pharmaceutical or biotech industry experience. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

• Excellent communication skills, drive, and sense of urgency.
• Excellent computer skills, specifically Microsoft Office Suite.
• Solid organizational and time management skills to prioritize activities in a manner consistent with departmental and site‑wide objectives.
• Follow strict internal protocols and SOPs as well as current cGMP, complying with legal regulations, monitoring the environment.
• Must have ability to work as a self‑starter and handle multiple priorities in a dynamic cross‑functional team‑based environment.
• Knowledge of pharmaceutical manufacturing and related documents.
• Knowledge and experience writing, revising and creating cGMP records and SOPs.
• Knowledge of GDP.
• Creation and maintenance of batch record and cGMP documentation templates.
• Closure of any compliance‑related CAPAs.
• Hands‑on experience facilitating problem solving and root cause investigations in a pharmaceutical environment – Develops, implements, and assesses solutions for complex problems.
• Ability to work effectively both independently and as part of…