Quality Systems Specialist – Direct Hire

Glen Rock, Pennsylvania

To apply, please email resumes to ian.thomas@elwoodprofessional.com

Text/call for more information: 812.558.0900

Company Profile:

• A small but prosperous company established in 1961 that has remained independent, and family owned since inception. Our mission has always been to develop, manufacture and deliver the world’s most innovative adhesives, coatings, and laminates for enhancing the performance of our customers’ products around the globe.
• Expert developer and manufacturer of high-performance adhesives, tapes, specialty films, coatings, laminates, release liners, and transdermal and trans-mucosal drug delivery technologies.

What This Company Offers You:

• Company benefits – Medical, Dental, Vision, Health care & dependent care reimbursement accounts
• Holidays eight (8) per year, vacation and PTO, ST and LT Disability options, 401k, and stock bonus plans
• Employee assistance programs, educational assistance, employee centric company culture, atmosphere, growth opportunities

The Role You Will Play: Quality Systems Specialist – Direct Hire

Responsible for leading the development, implementation, and maintenance of Quality Systems in support of pharmaceutical products to include, but not limited to: Policies and Procedures, Deviations, CAPA’s, Document, Validation, Internal Auditing, and support for Change Controls and Training.

Essential Functions:

• Independently prioritizes workload based on input from other functions, customer needs and business requirements.
• Comprehensively, accurately and independently conducts final review of all batch records, line clearances, supporting data and testing requirements assuring compliance with documented procedures, federal regulations and customer requirements. Issues and assigns deviations where appropriate; audits and facilitates timely resolution thereof.
• Facilitates product release and generation of certificates of compliance and analysis upon successful completion of batch record review and QC testing.
• Serve as liaison with customer and internal departments; ensuring that day-to-day goals are met, as well as coordinating timely release of product. Provide product release and any other documentation to customer as required. Coordinates shipping of certified material with Customer Services, Operations, and customers.
• Coordinates the generation, review, revision, approvals & training of all quality system procedures and related documentation including but not limited to: MSOPs, QSOPs, LSOPs, ACALs, Forms, PATM/ATM, Raw Material Specifications, Master Batch Records, change controls, preventive actions, validation protocols, etc.; creates and maintains electronic indexes thereof.
• Receives purchase order information from Customer Service, generates batch record numbers for batch record generation.
• Schedules, organizes and participates in internal and/or external audits (e.g., client, FDA, DEA, etc.).
• Processes and maintains all validation protocols.
• Helps with management of Preventative Actions, Deviations, Laboratory Investigation Reports and Change Controls in a backup function.
• Identifies and implements Continuous Improvement Initiatives
• Notifies appropriate associates when documents are updated and released; ensures functional and divisional compliance with training requirements.
• Identifies & implements opportunities for improvement in system effectiveness and productivity.

Background Profile: Quality Systems Specialist – Direct Hire

• REQUIRED; Bachelor’s degree in technical or engineering discipline and/or a minimum of 5 years of quality experience in Quality Systems; working knowledge of cGMP and GLPs. Ability to perform required duties independently, efficiently and effectively with minimal supervision.
• Able to use initiative in carrying out assignments independently without specific instructions; exercises sound judgment and discretion regarding when to request guidance and/or assistance from others.
• Ability to thoroughly review documents for accuracy and completeness.
• Ability to read and interpret documents such as test methods and procedure manuals. Ability to work with mathematical concepts such as averages, standard deviation and other basic statistical functions.
• Ability to operate computers and other office equipment; software package (e.g., Oracle, MS-Outlook, MS-Excel, MS-Word, Minitab, PDFs, SharePoint, scanning, etc.) competence for drafting documents as well as inputting, tabulating and retrieving data.
• Work environment can involve moderate risks or discomforts requiring special safety precautions, may be required to use personal protective equipment.
• Ability to maintain confidentiality of company and client information.
• Ability to conduct duties and interact with others (colleagues & external parties) in a professional manner.
• Ability to understand and conform to Company policies and procedures.

To apply, please email resumes to ian.thomas@elwoodprofessional.com

Text/call for more information: 812.558.0900

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