Entry Level Quality Assurance Lead Jobs

SUMMARY/OBJECTIVE: This position will inspect materials before, during and after production including filling and/or packaging to measure the characteristics of materials and ensure that they conform to specifications.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develops and maintains inspection reports.
• Prepares and maintains test data for review.
• Communicates quality or compliance concerns with urgency.
• Performs visual and functional inspection of materials against statistically based sampling plans using measuring devices such as balances, micrometers, and gauges to determine conformance to specifications. Materials include incoming raw materials, in-process products, and finished goods as applicable.
• Maintains detailed records of sampling, inspections, and testing activities.
• Performs room, equipment, and packaging line clearance checks prior to each stage of manufacturing following detailed written procedures.
• Conducts in process testing per manufacturing and packaging batch record instructions.
• Prepares finished product samples for QA retains following applicable SOP’s and customer requirements.
• Labels component receipt, visual examination, counting, preliminary inspection and sampling, and product reconciliation.
• Labels material for disposition in Warehouse area including Quarantine, Released, In-Process, Finished Goods, Returned Goods, client specific Retain Samples, R&D Use, and Rejected materials.
• Ensures the proper isolation of rejected material generated during batch process and accountability in the batch record.
• Verifies picked and packed materials for product distribution.
• Prepares samples for chemical analysis (performed offsite where required).
• In performing the above duties, the individual is responsible for accurately and clearly documenting inspection records in accordance with cGMPs.
• Prepares routine calibration reports, schedule calibrations with external service providers, review and approve calibration reports.
• Coordinates routine environmental monitoring with external service providers and review results.
• Supports equipment cleaning verification including swabbing equipment surfaces, transfer of swab samples to external testing partners, and review results.
• Carries out duties in compliance with all federal and state regulations and guidelines.
• Complies with all company and site policies and procedures including but not limited to safety, standard operating procedures, and work instructions.
• Remains current in profession and industry trends.
• Makes a positive contribution as demonstrated by:
• making suggestions for improvement.
• learning new skills, procedures and processes.
• Is available for other duties as required.
• Is available for overtime as needed.

QUALIFICATIONS AND EXPERIENCE:

• High school diploma or GED required with a minimum of 2 years of relevant experience OR Bachelor’s Degree in a Science field preferred with a minimum of 1 year of relevant experience.
• Familiar with cGMPs, EU, 21 CFR Part 210, 211, and 820, ISO and the USP.
• Excellent written and verbal communication skills with ability to give internal and external presentations.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) or related software.
• Excellent organizational skills and attention to detail.
• Demonstrated ability to read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.
• Legible handwriting.

COMPETENCIES/SKILLS:

• Read, write, review and interpret documents such as standard operating procedures, manuals, batch records, work instructions, specifications, protocols, contracts.
• Communicates clearly in writing and orally.
• Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios and proportions to practical solutions.
• Demonstrates effective collaboration and teamwork.
• Demonstrates experience working in a cGMP environment.
• Familiar with project management tools and technologies such as Microsoft Project.
• Successfully completes regulatory and job training requirements.
• Computer skills:
• Enter data into computer using software applications for data entry, data analysis, statistical analysis, and word processing.
• Proficiency with e-mail systems.
• Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
• Ability to work with others in a team environment.

SUPERVISORY RESPONSIBILITIES: None

SCHEDULE: On-site 5 days a week

SALARY: Non-exempt role: Up to $27/hour dependent on experience

WORK ENVIRONMENT: This job operates in a manufacturing/packaging/warehouse setting.

PHYSICAL DEMANDS:

• Ability to lift and/or move up to 50 pounds frequently preferred.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL:

• Travel will be required less than 10% of the time.