QA Reserve Sample Inspector Level 1 - 1st Shift

QA Reserve Sample Inspector Level 1

We are seeking a QA Reserve Sample Inspector Level 1 - 1st Shift (6AM - 2:30PM). Responsibilities include transferring of samples to appropriate storage locations, visual inspection of finished good customer samples and completion of necessary documentation and inventory transactions. Additionally, participation in internal, external or regulatory audits will be required at the discretion of senior management. The impact of the quality inspection process directly impacts company compliance to regulatory requirements and customer satisfaction.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of responsibilities related to Reserve Sample Inspector Level I. Other duties may also be assigned.

• Responsible to ensure and enforce GMP Compliance (including but not limited to gowning attire, personal hygiene, handling/storage of materials, and Good Documentation Practices) throughout the inspection and warehouse areas.
• Responsible for sampling and performing a visual inspection on all Customer Reserve Samples per the Work Instructions and/or inspection form.
• Responsible for packing Customer Reserve Samples in order to transfer to the final storage location.
• Responsible for reviewing work of peers at the discretion of QA Management.
• Responsible for scanning and archiving all completed inspection reports and associated documentation.
• Responsible for participating in internal, customer, and regulatory audits at the discretion of Senior Management.
• Responsible for training of designated peers at management request.
• Responsible for performing a physical inventory at the discretion of QA Management on all storage locations that contain Customer Reserve Samples.

SUPERVISORY RESPONSIBILITIES: None

QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• EDUCATION and/or EXPERIENCE: Bachelor's degree with a minimum of two years' experience and/or training. Associate's degree with two to four years' experience and/or training. High school diploma with four to six years' experience and/or training. Experience in inspection of pharmaceutical or related industry is preferred.
• General knowledge of FDA regulations related to cGMPs is required.
• General knowledge of Quality Control/Assurance is required.
• Good documentation and communication skills is required.
• Good organizational and planning skills is required.
• Prior experience driving a forklift is desired.
• Ability to multi-task when necessary is preferred.

MATHEMATICAL SKILLS: Ability to apply simple mathematical operations to assigned tasks.

LANGUAGE SKILLS: Ability to effectively communicate (either written or verbally) with the following groups: Internal: Daily contact with Compliance, Quality, Warehouse, and Customer Service Departments for information on sample inspection issues and cGMP issues. External: Minimal contact with customer representatives related to sample inspections.

REASONING ABILITY: A thorough understanding of each aspect of the job is required. Ability to make rational decisions pertaining to quality compliance. Ability to resolve problems effectively and efficiently.

COMPUTER SKILLS: Basic Windows applications, including Microsoft Office Suite. Experience with Lotus Notes and QAD desired.

PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee will frequently sit to complete paperwork. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and the ability to adjust focus.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to a hazardous environment or conditions. The noise level in the work environment is usually moderate.