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Sharp Corporation
Conshohocken, PA | Full Time
10 Months Ago
feine coffee
Conshohocken, PA | Full Time
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QA Supervisor - 2nd Shift
Sharp Corporation Conshohocken, PA
Full Time | Business Services 10 Months Ago
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Sharp Corporation is Hiring a QA Supervisor - 2nd Shift Near Conshohocken, PA

SUMMARY Responsibilities include supervision of quality activities, assessment for new and ongoing projects, providing direction regarding cGMP standards to direct reports. Responsible for contact with QA representatives from each customer regarding quality issues related to documentation and packaging process. Will participate in audits by customers and other regulatory agencies. Responsible for ongoing contact with internal Operations, Sales, Engineering and Quality Department employees concerning compliance with customer requirements as well as cGMP requirements specific to the site. 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 list of responsibilities may be distributed to multiple supervisors. Additional duties may also be assigned. Responsible for supervising quality functions including in-process inspections and finished product inspections. Responsible for participating in customer audits at the discretion of management. Responsible for follow-up on all customer audits specific to the site including assisting in the audit response and monitoring commitments specific to the related areas. Participate in internal audits at Sharp facilities. Responsible for investigation of deviations related to procedures, policies, specifications, or protocols. Participate in regulatory inspections at the local site at the discretion of Senior Management. Responsible for investigation of consumer complaints related to packaging that are received from customers. Review designated SOPs and make recommendations for revisions as needed to submit for management approval. Assist in appropriate problem-solving initiatives to address customer or regulatory quality issues as requested by Senior Management. Manage training of peers and subordinates. SUPERVISORY RESPONSIBILITIES: Direct supervision of all quality assurance inspectors at the local site. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE: Associates or Bachelor’s degree is preferred; or two to four years of related experience and/or training; or a high school diploma with three to six years’ related experience and/or training; or equivalent combination of education and experience. Experience in inspection of pharmaceutical or related industry is desired. - Knowledge of FDA regulations related to cGMPs is preferred. - Thorough knowledge of quality control/assurance and/or operations is preferred. - Good written and oral communication skills is required. - Good organizational and planning skills are required. MATHEMATICAL SKILLS: Ability to apply mathematical operations to such tasks as they apply to the pharmaceutical industry. This includes evaluation of statistical sampling plans. LANGUAGE SKILLS: Ability to read and interpret common scientific data. Ability to respond to common inquiries or complaints from customers, ability to direct and respond to inquiries from peers and subordinates. Ability to effectively present information to the following groups: - Internal: Frequent contact with Quality Department, and Operations Department employees for information exchange, collaboration, problem solving, direction regarding customer quality issues and cGMP issues. - External: Occasional contact with customer representatives conducting audits, planning new product introductions, addressing technical agreements and problem-solving quality issues specific to the site REASONING ABILITY: Ongoing contact with internal Operations and Quality Department employees. Occasional contact with customer representatives concerning compliance with specifications, as well as cGMPs. Customer agreements and regulatory guidelines are available to assist, however frequent review and reasonable interpretation are necessary to keep current. A thorough internal audit and follow-up program is necessary to prepare for customer audits and regulatory inspections. Good organizational skills are necessary. Good analysis and problem-solving skills are required. COMPUTER SKILLS: Must be proficient in Microsoft Office Suite. 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 accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee frequently is required to sit. The employee is required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. 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 accommodations 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 and is periodically required to stand and walk throughout the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions. The noise level is usually moderate. Approximately 1-5 percent auto travel between sites. Travel to customers on an as needed basis.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

POST DATE

05/22/2022

EXPIRATION DATE

11/20/2022

WEBSITE

sharpandco.com

HEADQUARTERS

BADEN, PA

SIZE

25 - 50

FOUNDED

1982

TYPE

Private

CEO

IFTIKHAR MALIK

REVENUE

<$5M

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