Packaging Documentation Specialist - MDI

Local applicants only – not for global assignments or employees working outside of Cipla's U.S. subsidiaries or affiliates.

FLSA Classification: Professional, Exempt
Work Location: Fall River, MA
Reports To: Packaging Manager

About the role

Invagen Pharmaceuticals is searching for an experienced Packaging Documentation Specialist. This role is responsible for the creation and revision of new and existing GMP batch production records and SOPs, ensuring accuracy, quality, and integrity in compliance with company procedures and regulatory standards. The position partners with cross-functional teams to support compliance and operational success at InvaGen Pharmaceuticals, Inc. in Fall River, MA.

Responsibilities

• Work with Manufacturing/Packaging to deliver timely batch record review across all shifts.
• Review and approve master batch records.
• Develop disposition metrics and collaborate with manufacturing/packaging personnel to achieve targets.
• Generate and report on metrics at agreed frequencies.
• Create training materials based on 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.
• Provide data to support management evaluation of performance trends.
• Own quality records (change control, CAPAs, deviations) and deliver to established timelines.
• Autonomously lead and manage 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.
• Anticipate risk and build contingencies to mitigate impact.
• Review documents for accuracy and completeness.
• Defend validation programs and strategies to customers and regulatory auditors.
• Perform weekly quality reviews of the Master Control database, ensuring new documents are entered using appropriate protocols.
• Follow internal protocols, Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), legal regulations, and environmental monitoring.
• Perform other duties as assigned.

Requirements

• Associate degree with 1–3 years of GMP documentation experience or 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 preferred.
• Minimum one (1) year of documentation experience and three (3) years of related pharmaceutical or biotech industry experience.
• Preference given to candidates with experience in generic pharmaceutical manufacturing, particularly inhalation products (MDI).
• Knowledge of pharmaceutical manufacturing and related documents, including writing, revising, and creating cGMP records and SOPs.
• Experience with deviation, CAPA, change control, FMECA, OOS, OOT, training, and OOAC processes.
• Knowledge of SAP systems, Master Control, and TrackWise systems is a plus.
• Knowledge of preparation of BMR, eBMR, SOPs, and eLog books.
• Experience facilitating problem-solving and root cause investigations in a pharmaceutical environment.
• Ability to work effectively both independently and as part of a team.
• Capability to handle and participate in compliance and regulatory audits at local and federal levels.

Skills

• Excellent communication, organizational, and time management skills.
• Proficiency in Microsoft Office Suite.
• Ability to prioritize activities in alignment with departmental and site-wide objectives.
• Strong attention to detail and ability to work in a dynamic, cross-functional team environment.
• Self-motivated with the ability to handle multiple priorities in a fast-paced manufacturing setting.
• Flexibility to adapt to changing work environments and schedules.
• Basic to intermediate computer skills (Word, Excel) and good math knowledge.
• Knowledge of statistical packages is a plus.
• Proficiency in English (reading, writing, and speaking).
• Knowledge of good manufacturing practices (GMP) and good documentation practices (GDP).

Schedule

• General shift: 8:30 AM – 5:00 PM (may vary based on business needs).
• Must be willing to work some weekends based on business needs.
• No remote work available.

Pay

Salary Range: $66,300 – $86,000