Operations Investigator - DPI

Job Title

Operations Investigator (Manufacturing and Packaging)

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

Hauppauge, Long Island

Employment Type

Full Time

Hourly Rate

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance – medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) – vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.

Work Hours/ Shift/ Remote

 9:00am -5:30pm

OT as required

Responsibilities/ Accountabilities

• Investigation of manufacturing and packaging deviations and non-conformances to determine root cause and implementation of Corrective and Preventative Actions (CAPAs) to prevent recurrence.

• Work with cross-functional teams to gather data, lead, and perform Root Cause Analysis to determine the likely root cause of the event. 
• Preparing investigation reports that include recommendations on investigation findings for medium/high severity non-conformances and communicating findings and recommendations at group meetings.

• Ability to conduct in-depth interviews and gather pertinent information to drive root cause conclusions, product impact analyses, and initiations of CAPA actions.

• Reviewing completed Batch manufacturing Records (BMR) and logbooks following cGMP standards in support of investigations.
• Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) following cGMP standards to ensure compliance with written procedures.
• Monitoring production processes to acquire vital data in support of investigations and track the efficiency of changes.
• Gathering, trending, and analyzing process-related data to drive consistency and timeliness.
• Training new employees in investigative processes and techniques and documenting all training.
• Coordinating and/or leading cross-functional meetings with multiple departments.
• Prepare product complaint investigations, assist in investigating quality issues, OOS, and OOT, and prepare reports for the same.
• Evaluating, developing, and qualifying manufacturing equipment (IQ, OQ, and PQ) and preparing necessary PQ protocols.
• Risk assessment and risk mitigation by performing FMECA (Failure modes, effects, and criticality analysis)

Education Qualifications

•  A bachelor's or advanced degree in pharmaceutical sciences, chemistry, or a related field is typically required.

Experience

• 2-5+ years’ experience

Skills/ Competencies

• Proficiency with Microsoft Office, SAP, Track wise.
• Strong analytical skills and proven organizational ability and attention to detail.
• Strong verbal and written communication skills.
• Ability to multitask and work in a fast-paced environment under tight deadlines
• Ability to think analytically, apply sound judgment, and solve problems

• Strong command over written and verbal English is required.
• Interpersonal skills.

• Maintains knowledge of current good manufacturing practices.
• General understanding of equipment, instruments, and systems involved in the manufacturing process.
• Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
• Experience interacting with regulatory health authorities if needed.
• Knowledge of global regulations and standards.
• Ability to follow gowning procedure and work in a production environment.