Quality Inspector

Candidate must be able to work a 3rd shift schedule. Sunday to Thursday 10pm to 6am.  

Summary

The Quality Inspector will provide quality-support to the packaging area, to include oversight for adherence to cGMPs FDA, and DEA compliance. The Quality Inspector will utilize practices and techniques within the disciplines of Quality Control, Quality Assurance, and Quality Improvement disciplines

General Duties and Responsibilities:

Adheres to proper cGMP’s including good housekeeping, proper protection of product quality and integrity, and personal hygiene.Reads and understands written instructions and SOPs.

• Knows and understands quality-related SOP requirements that determine appropriate process for conducting job performance.
• Knows and understands applicable regulatory requirements that impact job performance.
• Makes sure relevant activities fall within SOP and regulatory requirements to ensure product conformity.
• Prioritizes multiple tasks simultaneously & completes tasks in timely manner.
• Reviews Master Batch Record for accuracy prior to packaging run.
• Checks, verifies, corrects, and approves component and quantities release for production.
• Checks product lot number information.
• Reviews inserts and outserts & product sample for accuracy.
• Reviews and approve tray & box labels for accuracy.
• Issues correct labels for production run and quantity.
• Conducts line verifications.
• Conducts product in-process inspections at designated intervals.
• Performs final QA inspection for finished product release.
• Verifies Packaging Personnel reconciliation for accuracy on finished product release.
• Prepares & print outer box release stickers when finished product is approved for release into inventory.
• Fills in “Product Release” Form P147.10 with required information.
• Inspects Packaging Room Clean/Clear status & approve its use for next packaging run.
• Performs Master Batch Record data entry in required spreadsheets.
• Receives label inventory (review/verify information; data input).
• Reconciles label inventory sheets.
• Ensures required approved forms are available in vestibules for packaging personnel use.
• Reviews and disposes customer returns (return to inventory or morgue product).
• Performs quality duties as assigned

Equipment:

Standard office equipment, computers, full-body suit, goggles, cap, booties, respirator and gloves.

Physical/Cognitive Requirements:

• Effective communication skills at all levels both written and verbal.
• Effective skills in analytical thinking and problem solving.
• Ability to perform multiple tasks and ability to effectively manage conflict.
• Ability to work in teams to obtain results.
• Must be a self-starter than can work independently on assigned project but know how to ask for help when needed.
• Time management and planning skills are essential, as well as excellent interpersonal skills in order that the incumbent may work effectively with the auditee and assure timely implementation of corrective measures following audits.
• Intermediate computer skills and strong internet research skills is required.
• Must have the ability to adapt work through conflicts and persuasively influence outcomes.
• Can effectively cope with change and is comfortable changing direction and acting without complete information.
• Strong organizational and prioritization skills.
• Team player works with others effectively respectfully and cordially.
• Executes plans to resolve basic to moderately complex problems.
• May be required to work longer than the typical 8-hour work day.
• Regularly required to stand; walk; use hands to fingers, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Must be capable of moving freely throughout the building and picking up, pushing, pulling and carrying items weighing up to 50lbs.
• Specific vision abilities required includes close vision, distance vision, color vision, peripheral vision, depth vision, depth perception, and ability to adjust focus.

Computer Skills: Intermediate keyboarding skills required

Miscellaneous Requirements:

• One + years of experience in pharmaceutical manufacturing preferred.
• Quality auditing experience preferred, either in Quality Assurance or Quality Control. 
• Knowledge of federal and state laws and regulations, and accreditation standards.
• Knowledge of quality system regulations/requirements (i.e. ISO – International Organization for Standardization, FDA – Food and Drug Administration, and GMP – Good Manufacturing Practices.
• Knowledge of manufacturing processes and relevant statistical techniques (Six Sigma, Statistical Process Control (SPC).
• Maintain a strong attendance record.
• Must be able to pass screening, drug test and background check. Adhere to company’s drug-free workplace policies.
• Skill in using precision tools. Must be able to effectively research, compile, sort, and present information and reports.