Senior Quality Specialist at SHARP STERILE MANUFACTURING LLC

Allentown, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Jul, 26

Salary

0.0

Posted On

05 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP guidance, Quality oversight, FDA regulations, Pharmaceutical packaging, Non-conformance investigations, CAPA, Continuous improvement, Data analysis, QMS, Process control, Internal auditing, Regulatory compliance, SOP development, Calibration oversight, Technical writing, Risk assessment

Industry

Pharmaceutical Manufacturing

Description

SUMMARY: Senior Quality Specialist provides quality oversight, GMP guidance and support and makes quality-related decisions for the designated functional areas within Sharp Commercial sites. They work closely with internal teams and customer quality representatives on a routine basis. The Senior Quality Specialist serves as a Quality SME and are responsible for leading, supporting, designing, and implementing GMP initiatives and continuous improvement opportunities within the Quality Operations organization through data analysis, training, motivation and coaching in collaboration with internal and external stakeholders. Must possess strong working knowledge of FDA regulations pertaining to Pharmaceutical /Pharmaceutical Packaging Operations. Scope of the position includes Allentown, Macungie and/or Conshohocken. The impact of decisions relating to customer interface, quality inspections, and documentation requirements could expose the company to significant risk or economic loss. ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities for the Senior Quality Specialist. Other duties may also be assigned. Collect and summarize data, draw conclusions, turn recommendations into clear communication. Turn data into improvements by facilitating and driving actions from analysis. Lead and take active role in non-conformance investigations that identify robust root cause and effective CAPA and Continuous Improvement planning. Manage relationships with customers, ensuring quality standards are aligned, and meeting customer needs. Review and approve Master Packaging Records for new projects and existing records for updates and all corresponding documentation. Complete QMS actions related to change controls, non-conformance, complaints and CAPAs. Identifies issues and can independently assess the need for non-conformance and utilizes good judgement and rationale to determine the appropriate containment actions in conjunction with operational leadership. Proactively identify and facilitate resolution of potential risks. Implement methods for process control, process improvement, testing and inspection. Ensure testing and inspection meet internal and external requirements. Audit internal processes on shop floor and warehouse and support internal stakeholders (operations, sales, customer service, project management, validation, and engineering) to ensure compliance of processes and product. Author, review and / or approve quality documentation including work instructions, SOPs, Quality Forms, etc. Provide Regulatory and Customer Audit Support /assist in providing observation response. Represent Sharp Quality Operations as the main point of contact / SME for customer meetings and calls. Collect and present customer KPIs as required. Oversee testing equipment calibration to ensure timely calibration and repair. Support DEA requirements and DEA Compliance Support training department to identify new opportunities for training program. Train colleagues Ability to serve as the alternate for the Quality Manager role during Manager’s absences as requested. Provide support to the audit team for items relevant to quality processes and procedures. Ability to simultaneously manage multiple tasks. Must be flexible to meet the needs of the organization when required. SUPERVISORY RESPONSIBILITIES: Indirectly provides guidance and leadership to the Quality Specialists and Quality Line Associates on the shop floor. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with minimal supervision. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. REQUIREMENTS: Due to the nature of our work, all employees must be over the age of 18 and will be required to undergo a pre-employment drug test and background check. EDUCATION and/or EXPERIENCE: Bachelor’s degree is preferred with three to five years related experience or associate’s degree with five to seven years of related experience or a minimum of seven years of related experience. Experience in inspection of Pharmaceutical or related industry is required. Outside certification of quality skills and practices (i.e., ASQ, CQIA, CQI, CQT, Lean Six Sigma etc.) is highly desired. MATHEMATICAL SKILLS: Ability to apply moderately complex mathematical operations including an understanding of statistical skills. LANGUAGE SKILLS: Ability to effectively communicate (written and verbally) with the following groups: Internal Communication: Quality, Operations, Sales, Customer Service, Project Management, Validation, and Engineering teams. External Communication: Represents Quality as the subject matter expert (SME) for customers and regulatory agencies on Quality Operations-related processes and issues. WRITTEN SKILLS: Above average writing and verbal skills, ability to provide clear, concise, and legible communication within written procedures, internal and external correspondence, such as memos to file, electronic mail and non-Conformance and procedure writing. REASONING ABILITY: Ability to make independent rational decisions pertaining to Quality Compliance is required. Ability to resolve problems effectively and efficiently. COMPUTER SKILLS: Intermediate Windows applications including Microsoft Office Suite and electronic QMS. Experience in statistical software such as Minitab a plus. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions. Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.

Responsibilities

The Senior Quality Specialist provides quality oversight and GMP guidance for pharmaceutical packaging operations while leading non-conformance investigations and continuous improvement initiatives. They act as a subject matter expert for internal and external stakeholders, ensuring compliance with regulatory standards and managing quality documentation.