QA Mfg Inspector I - 2nd Shift

Cipla USA; Fall River (MA); On-site; USD 40,000 - 80,000; Full time

Job summary

Join a dynamic team as a QA Manufacturing Inspector, where your expertise in quality assurance will ensure product excellence in a fast-paced pharmaceutical environment. This role involves performing critical in-process testing, conducting thorough inspections, and maintaining compliance with Good Manufacturing Practices (cGMP). You'll work closely with the Quality Assurance team to uphold the highest standards of quality throughout the manufacturing process. If you are detail-oriented, proactive, and passionate about quality assurance, this is your chance to make a significant impact in a leading pharmaceutical company. Embrace the opportunity to grow your career in a supportive and collaborative work environment.

Qualifications

• Minimum high school diploma required, vocational training preferred.
• 3+ years experience in quality assurance in GMP environments.

Responsibilities

• Perform in-process testing and inspections as per batch records.
• Monitor environmental conditions and maintain quality records.
• Identify and report non-conformances to management.

Skills

Good Manufacturing Practices (cGMP)

Attention to Detail

Interpersonal Skills

Microsoft Office

SAP

Organization Skills

Communication Skills

Education

High School Diploma

Vocational Training in Pharmaceutical Manufacturing

Tools

Microsoft Office

SAP

Job description

Job Title: QA Manufacturing Inspector - On-the-floor Inspector

FLSA Classification: Full-Time, Non-Exempt/Hourly Professional

Work Location: Fall River, MA

Work Hours: Second Shift: 03:00PM – 11:30PM (May vary based on business needs)

Reports To: Quality Assurance Supervisor

PURPOSE

The purpose of the QA Manufacturing Inspector position is to monitor and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs).

SCOPE

The scope of this job description is designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job. This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications. The intent of this job description is to be representative of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position in accordance with the established performance expectations.

JOB DESCRIPTION

The Quality Assurance (QA) Inspector position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The position reports to the Manager of QA and may be matrixed to other functional leaders within the Quality or other departments. The essential and typically expected job duties for this position include but are not limited to the following:

• Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
• Conduct room and equipment checks (where applicable) prior to each stage of manufacturing by following detailed written procedures.
• Execute acceptable quality limit (AQL) sampling and inspections as required.
• Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab and follow detailed documentation procedures to deliver the results to the QC Lab.
• Maintain records of standard weights and perform daily verification of balances.
• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.
• Monitor facility and product environmental operating conditions.
• Review engineering records such as temperature and humidity data calibration and PM records, Pest control records and contractor related functions.
• Assess online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.
• Verify the functionality of all the equipment and associated controls during the batch run.
• Perform applicable testing and prepare reports for customer complaints.
• Identify and report any non-conformances and/or discrepancies to management if applicable.
• Complete other duties or participate in project work as assigned by management.

EDUCATION AND EXPERIENCE QUALIFICATIONS

• Minimum high school diploma.
• Advanced vocational training or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university is preferred.
• Minimum of three (3) years’ experience in quality assurance in a GMP pharmaceutical manufacturing operation and work environment.
• Experience in MDI preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

• 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 have strong attention-to-detail.
• Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and communication skills (written, verbal, and presentation).
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.

OTHER JOB INFORMATION

• No remote work available.