Experic is an industry-leading contract development and manufacturing organization (CDMO) and clinical trial supply services company. Our vision is to deliver innovative and scalable solutions for every phase of a product's life cycle from clinical to commercial. We offer advanced pharmaceutical manufacturing, packaging, and labeling technologies that can accommodate a variety of dosing and packaging formats. We take pride in our precision capabilities, state-of-the-art filling equipment, advanced technologies, and Class A regulatory compliant cGMP facilities. Our main goal is to provide our clients personalized attention and ensure the smooth and successful completion of their pharmaceutical development programs.

We aspire to develop a team culture based on trust, integrity, ethical behavior, and compliance, with a relentless focus on delivering high quality results. If you value a collaborative work environment and are energized by the opportunity to truly make a difference, come and Experience the Experic difference. We believe in fostering a fair and respectful work environment that encourages open communication and continuous improvement. At Experic, you can experience a fulfilling career, do meaningful work, and grow professionally and personally. A successful candidate will bring their unique thinking, expertise, and approach while sharing our core values.

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 include the following. Other duties may be assigned.

• 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

ADDITIONAL POSITION REQUIREMENTS

• 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.
• 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
• Is available for other duties as required.
• Is available for overtime as needed.

QUALIFICATIONS: EDUCATION and/or EXPERIENCE

• High school diploma or GED required with a minimum of 2 years of relevant experience preferred
• 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

LANGUAGE 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.

MATHEMATICAL SKILLS

• Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios and proportions to practical solutions.

OTHER SKILLS, ABILITIES OR QUALIFICATIONS

• 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.
• Work and be proficient 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.

PHYSICAL DEMANDS

• While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
• The employee is occasionally required to sit and reach with hands and arms.
• Ability to lift and/or move up to 50 pounds frequently preferred.
• The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.