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Visual Inspection Associate – Sterile Compounding

Remedy
Houston, USA
Mid
Onsite
Discovered 1 weeks ago

Full Job Posting

Comp | Perks | Benefits

This is an onsite position located in Missouri City, TX

Robust and affordable Medical, Dental, and Vision plan options

Vacation time off policy - up to 10 vacation days accrued your first year. Vacation time begins accruing immediately

Base pay offered may vary depending on job-related knowledge, skills, and experience.

Sterile Product Visual Inspection

Perform visual inspections of sterile compounded pharmaceutical preparations, including injectable medications packaged in vials, syringes, and other sterile containers, as applicable

Inspect products for visible particulate matter, discoloration, cloudiness, clarity issues, and other observable product defects

Examine containers for visible cracks, leaks, damaged closures, compromised seals, and other observable container integrity concerns

Follow approved inspection procedures, established acceptance criteria, and standard operating procedures (SOPs) to ensure consistent inspection practices

Utilize designated inspection stations, lighting, contrasting backgrounds, and other approved visual inspection equipment

Identify and appropriately segregate products that fail established visual inspection acceptance criteria

Promptly escalate suspected defects, inspection discrepancies, and product quality concerns to QA Compliance

Maintain consistent inspection accuracy and attention to detail while performing repetitive inspection activities

Complete required visual inspection training, qualification assessments, and periodic competency evaluations

Quality & Compliance

Perform inspection activities in accordance with USP <797>, applicable state Board of Pharmacy regulations, and facility SOPs

Follow established procedures for product handling, inspection, segregation, and escalation of nonconforming products

Ensure inspection activities support product quality, patient safety, and established regulatory requirements

Maintain clean, organized, and compliant visual inspection workstations

Follow approved procedures for the proper handling and protection of sterile compounded preparations

Report observed defects, discrepancies, equipment concerns, and deviations promptly to QA Compliance

Support internal audits, regulatory inspections, and ACHC/PCAB accreditation readiness through accurate inspection practices and documentation

Participate in ongoing training and continuous improvement initiatives related to visual inspection accuracy, consistency, and compliance

Inspection Documentation & Traceability

Accurately complete visual inspection records, including product identification, lot or batch information, inspection results, and identified defects

Document inspection outcomes in accordance with established procedures and good documentation practices

Maintain complete and traceable records of inspected, accepted, rejected, and segregated products

Ensure inspection documentation is completed accurately and contemporaneously

Record and escalate recurring defects, inspection discrepancies, or unusual product observations to QA Compliance

Support the maintenance of inspection logs, equipment records, and qualification documentation

Assist QA Compliance with inspection record retrieval and documentation reviews during audits or regulatory inspections

What you bring to the role

High school diploma or equivalent required

Previous experience in pharmaceutical manufacturing, sterile compounding, visual inspection, or a regulated production environment preferred

Experience performing visual inspections of sterile pharmaceutical products, including injectable preparations, vials, or syringes, strongly preferred

Familiarity with visible particulate inspection, pharmaceutical container defects, and established inspection acceptance criteria

Understanding of USP <797>, pharmaceutical quality standards, or regulated pharmacy operations preferred

Exceptional attention to detail and ability to identify subtle visual defects and product abnormalities

Ability to consistently perform repetitive, detail-oriented inspection tasks while maintaining accuracy and focus

Strong organizational skills and ability to maintain accurate inspection records and documentation

Ability to follow detailed written procedures, inspection criteria, and SOPs without deviation

Strong communication skills and ability to promptly escalate product quality concerns

Ability to work independently while collaborating with QA Compliance and pharmacy operations

Ability to successfully complete required visual inspection training and qualification assessments

Bonus Points

Experience performing manual visual inspection of sterile injectable pharmaceutical products

Experience in a 503A compounding pharmacy, FDA-registered 503B outsourcing facility, or sterile pharmaceutical manufacturing environment

Familiarity with USP <797> requirements and sterile compounding quality standards

Experience using visual inspection booths, specialized lighting, contrasting backgrounds, or semi-automated inspection equipment

Knowledge of visible particulate identification, container closure defects, and inspection acceptance criteria

Experience documenting inspection results, defect classifications, and rejected product dispositions

Familiarity with ACHC/PCAB accreditation standards and pharmacy quality documentation requirements

Knowledge of good documentation practices (GDP) and applicable cGMP principles

Previous experience working closely with Quality Assurance or QA Compliance teams

Physical Requirements

Extended periods of sitting or standing while performing detailed visual inspection activities

Ability to perform repetitive fine-motor tasks and handle pharmaceutical containers with precision

Visual acuity, with or without corrective lenses, sufficient to meet established inspection qualification requirements

Ability to maintain sustained visual concentration and attention to detail throughout inspection activities

Ability to safely handle sterile pharmaceutical containers and operate designated inspection equipment

Work in a controlled pharmaceutical environment requiring appropriate protective clothing and personal protective equipment (PPE)

Ability to follow applicable hygiene, gowning, and safety requirements

Ability to lift up to 35 lbs

All Company policies and procedures are subject to change without notice based on business needs. This includes, but is not limited to, the locations where we hire remote, hybrid, or onsite employees.

U.S. Applicants Only

Don’t meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Remedy we are dedicated to building a diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions. Contact us at [email protected] to request accommodation.

This employer participates in E-Verify and will provide the federal government with your I-9 Form information to confirm that you are authorized to work in the U.S.

Please be aware that there are fraudulent entities who are falsely claiming to be or represent Remedy in order to solicit sensitive personal information or payment. Remedy is not in any way associated with these entities or practices. The safety and integrity of those seeking employment with us is of the utmost importance and we actively work with our legal and security teams to prevent future incidents.

Remedy will never ask for sensitive information or payment when engaging with job seekers. The entities use many methods to perpetuate these scams, including but not limited to: participating in a text-only interview, using Remedy's trademarks on their correspondence, or providing you with a seemingly legitimate offer letter. If you suspect you are a victim of this scamming, we encourage you to cease further contact and report the crime to The Federal Trade Commission.

Qualifications

  • Familiarity with visible particulate inspection, pharmaceutical container defects, and established inspection acceptance criteria
  • Familiarity with USP <797> requirements and sterile compounding quality standards
  • Familiarity with ACHC/PCAB accreditation standards and pharmacy quality documentation requirements

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