QA Operations Specialist

Cipla•Fall River, MA

2d•Onsite

About The Position

The QA operation specialist (MDI) position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The QA operation specialist (MDI) monitors and ensures 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 provide guidance to QA associates.

Requirements

Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university.
Bachelor’s degree 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.
Minimum of five (5) years’ experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment.
Current, working knowledge of quality assurance (QA).
Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good Distribution Practices (GDP), etc.
Understanding of machines used in pharmaceutical manufacturing.
Must be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.
Effective interpersonal relationship skills and the ability to work in a team environment.
Capable of conducting troubleshooting, investigations and root cause identification and analysis.
Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
Must be proficient in computer skills and software applications such as Microsoft Office tools.
Experience using SAP business system and applications is a plus.
Experience in Inhalation products (MDI) or Combination products is a plus.
Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting.
Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally.
Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
Must be able to work under minimal supervision and able to work independently and in a team environment.
Must be able to exercise appropriate professional judgment on matters of significance.
Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications.
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.
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.
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.

Nice To Haves

Bachelor’s degree in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is preferred.
Experience in MDI or combination products is preferred.
Experience using SAP business system and applications is a plus.
Experience in Inhalation products (MDI) or Combination products is a plus.

Responsibilities

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.