QC Sampling & Inspection Technician

Unither Pharmaceuticals; City of Rochester (NY); On-site; USD 45,000 - 65,000; Full time

Job summary

Unither Pharmaceuticals in Rochester, NY is seeking a QC Sampling & Inspection Technician. This pivotal role involves performing sampling and inspection of incoming drug substances, raw materials, and packaging components, adhering strictly to SOPs and cGMP regulations. The technician will be involved in conducting utility sampling and analyzing inspection results while maintaining necessary supplies. Candidates should possess a High School Diploma or Associate's Degree with relevant experience and strong attention to detail. Additional skills in computer applications are preferred.

Qualifications

• 2-5 years of experience in a regulated environment or 1-2 years with an Associate's Degree.
• Experience in a cGMP environment.
• Ability to read, communicate, and legibly write in English.

Responsibilities

• Perform routine sampling of raw materials and packaging components.
• Analyze inspection test results for conformity.
• Maintain supplies for sampling and inspection activities.

Skills

Sampling and aseptic techniques

Written documentation practices

Attention to detail

Basic computer skills (Outlook, Word, Excel)

Strong math skills

Familiarity with LIMS and inventory management systems

Education

High School Diploma/GED

Associate's Degree

Tools

SAP

Job description

QC Sampling & Inspection Technician

Reporting to the Microbiology Manager, the QC Sampling & Inspection Technician performs sampling and inspection of incoming drug substances, raw materials, and packaging components following applicable SOPs and cGMPs. The role also provides sampling and incoming inspection support for development projects.

Responsibilities

• Perform routine sampling of raw materials and packaging components.
• Perform utility sampling for purified water, water for injection, and pure steam.
• Analyze inspection test results to ensure conformity to specifications.
• Maintain and stock supplies required for sampling and inspection activities.
• Identify and communicate actual and potential problems; support investigations and troubleshooting as needed.
• Write basic investigations with assistance.
• Follow aseptic gowning standards.
• Perform data entry and fill out paperwork following SOPs and cGMP/GDPs.
• Review colleague work for accuracy in accordance with SOPs and cGMP/GDP requirements.
• Maintain and update training records as required by applicable procedures.
• Monitor and maintain equipment certification/calibration schedules.
• Participate in investigations as required.

Qualifications

• High School Diploma/GED with 2-5 years of experience in a regulated environment, or an Associate's Degree with 1-2 years of experience in a regulated environment.
• Experience with sampling and aseptic techniques.
• Experience in a cGMP environment.
• Experience in written documentation practices.
• Ability to read, communicate and legibly write in English.
• Strong math skills with attention to detail.
• Ability to quickly learn and demonstrate comprehension of cGMPs and SOPs.
• Basic computer skills (Outlook, Word, Excel).
• Familiarity with LIMS and inventory management systems (e.g., SAP) desirable.

Physical Requirements

• Visual acuity, color recognition, finger dexterity.
• Reading, writing and communication in English.
• Work involves chemical and biological agents with associated hazards.
• Approx. 30% sitting; 70% standing/walking.
• Repetitive hand use (keyboarding, grasping, fine manipulation).
• Occasional lifting up to 50 pounds.
• Normal office environment; occasional controlled environment work requiring removal of jewelry and cosmetics.
• Occasional weekend, holiday, and irregular hours.

Decision Making & Supervision

Decisions require some judgment: perform repetitive or routine duties from detailed instructions, under standard procedures, and make minor decisions. Project direction of other employees performing the same or directly related work.

Internal/External Contacts

Primarily interacts within department or immediate work unit; contacts other departments; occasionally contacts individuals outside the organization as needed.

Unither is an Equal Opportunity Employer. We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.