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Pilot Plant QA Operations Specialist
3 months ago
FLSA Classification: Professional, Exempt
Work Location: Fall River, MA
Work Hours: General: 8:30AM - 5:00 PM (may vary based on business needs)
Reports To: Head, Pilot Plant
**Job Title**:QA operation specialist (MDI)
**Location**:Fall River, MA
**Job Purpose**:
The purpose of the QA operation specialist (MDI) position is to monitor and ensure validation and qualification of facility, utilities, equipment’s, processes and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs) and to provide guidance to QA associates.
**Duties and Responsibilities**:
The QA operation specialist (MDI) position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The essential and typically expected job duties for this position include but are not limited to the following:
- Review of batch manufacturing/packaging record.
- Review of engineering records such as temperature and humidity data calibration and PM records, pest control records and contractor related functions.
- Review and approval of manufacturing/engineering non-conformances.
- Review and approval of manufacturing/engineering change control, deviation investigation and CAPAs.
- Review and approval of manufacturing/engineering validation and qualification documents.
- Provide daily/weekly updates to shop floor and management regarding the quality highlights/concerns.
- Create lessons learned for training as communication mechanism to shop floor personnel.
- Perform applicable testing and prepare reports for customer complaints.
- Identify and report any non-conformances and/or discrepancies to management if applicable.
- Verify functionality of all the equipment and associated controls during the batch run.
- Act as quality lead for all shop floor questions / concerns.
- Backup for shop floor QA Associates.
- Complete other duties or participate in project work as assigned by management.
**Education and Experience**:
- Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university.
- Bachelor’s degree in in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is preferred.
- Minimum of five (5) years’ experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment.
- Experience in MDI or combination products is preferred.
**Professional and Behavioral Competencies**
- Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
- Effective interpersonal relationship skills and the ability to work in a team environment.
- Proficiency in the English language to include usage, spelling, grammar, and punctuation.
- Must have current Good Manufacturing Practices (cGMP) knowledge.
- Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
- Must have strong organization and leadership skills (written, verbal, and presentation).
- Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.
**Physical requirements**
- Work standing or walking unassisted for 75% or greater of an 8-hour period. Unassisted lifting up-to 10 kg, may be required.
- Able to always wear appropriate personal protective equipment, when required.
- Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period.
**Other Job Information**
- Must be willing to work in pharmaceutical manufacturing and packaging quality assurance.
- Must be willing and able to work any assigned shift ranging from first or second shift. Work schedule may be Monday to Friday.
- Must be willing to work some weekends based on business needs as required by management.
- No remote work available.
**Working conditions**
This role works in a cGMP manufacturing environment, where personal protective equipment is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. Work with or around solvents, powders, or other materials commonly found in a pharmaceutical manufacturing facility is required.
The role may be assigned on a work-shift basis, where required (Day, Evening, Night). Weekend or Holiday work may be requested or required.
**GLOBAL COMPANY**
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and oth
