What are the responsibilities and job description for the Incoming Inspection Supervisor position at Sharp Clinical Services?
SUMMARY:
Responsibilities include supervision of incoming Quality Assurance activities and providing directions for cGMPs to direct reports. The QA Incoming Inspection Supervisor will have frequent contact with QA representatives from customers and vendors as well as internal Operations, Sales, Materials Management, Engineering and Quality Assurance associates concerning incoming inspection activities. Participate in audits by customers and other regulatory agencies.
Scope of the position includes the Quality Assurance incoming inspection function at the local 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 all-inclusive list of responsibilities may be distributed to multiple supervisors. Other duties may also be assigned.
Responsible for the management of assigned subordinate Inspectors, including but not limited to:
Training, scheduling and assignment of staff to meet all incoming inspection
requirements.
Oversight of Inspector operations to ensure timely review and disposition of
incoming materials (including bulk products, raw material and components)
Completion of annual performance reviews.
Managing disciplinary action issues in conjunction with manager.
Completion and documentation of subordinate training.
Responsible for the incoming inspection process of DEA classified drugs, other drug products and medical devices.
Responsible for the identity testing of containers and closures (films, foils, pouches, bottles, caps, etc.) used in the packaging of the company’s products.
Responsible for overseeing the reject cage and supporting efforts to review and disposition nonconforming bulk products, components and materials.
Responsible to ensure and enforce GMP compliance (including but not limited to gowning attire, personnel hygiene, handling/storage of materials and good documentation practices) throughout the inspection and warehouse areas.
Responsible for processing applicable DMR’s (Deviated Material Reports), Investigations and any other applicable Quality Systems associated with QA Incoming Inspections.
Responsible for maintaining bulk products, component and raw material specification and inspection files.
Draft, review and revise SOP’s and specifications on a designated basis to ensure accuracy.
Responsible for participating in internal and external audits at the discretion of management.
Responsible for follow-up on audit observations specific to the related areas.
Responsible for reporting departmental metrics to senior management monthly.
Responsible for overseeing the Pest Control program for all applicable facilities.
Responsible for assuring all test equipment is within the calibration due dates.
Capable of using measuring tools, i.e. calipers, rulers, micrometers, etc.
Capable of using the FTIR and Global Vision System to perform inspections on films, foils and printed components.
Assist in appropriate problem-solving initiatives to address customer or regulatory quality issues as requested by Senior Management.
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.
SUPERVISORY RESPONSIBILITIES:
Direct supervision of all incoming quality assurance inspectors and lead inspector(s) 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. The individual must pass a color blindness test to assure they can detect if a color is out of specification. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
Associates degree is required with four to six years’ related experience.
Bachelor’s degree is required with three to five years related experience.
Experience in pharmaceutical or related industry is required.
- Knowledge of FDA regulations including cGMP’s and current industry practice
- Thorough knowledge of quality control/assurance is required.
- Knowledge of DEA regulations is required.
- Good computer skills in excel, word and access is required.
- Good written and oral communication skills are required.
- Good organizational and planning skills are required.
- Knowledge of QAD and Pilgrim is desired.
MATHEMATICAL SKILLS:
Ability to apply moderately complex mathematical operations including an understanding of statistical sampling plans and the ability to calculate time, percentages and decimals. Basic math skills (addition, subtraction, multiplication and division) are required.
LANGUAGE SKILLS:
Ability to read and interpret common scientific data. Ability to respond to common inquiries from customers. Ability to direct and respond to inquiries from peers and subordinates. Ability to effectively present information to the following groups:
- Internal: Daily contact with Quality, Operations, Material Management and Account Management department associates for information exchange, collaboration, problem solving, and direction regarding the incoming inspection process and cGMP issues.
- External: Frequent contact with customer and vendor representatives concerning activities related to the incoming inspection process which include but are not limited to specification requirements, inspection results and nonconformance reporting.
REASONING ABILITY:
Ability to make rational decisions pertaining to quality compliance is required. Ability to resolve problems effectively and efficiently is required.
WRITTEN SKILLS:
Ability to provide clear, concise and legible documentation within batch records, forms, and/or memos to file in conformance with basic Good Documentation Practices. Technical writing skills are required.
COMPUTER SKILLS:
Must be proficient in Basic Windows applications such as Lotus Notes & Microsoft Office Suite. Familiarity with Pilgrim and QAD desired.
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. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. The employee must work with handheld measuring instruments and precision weighing scales.
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 work in all the warehouse areas of the local site. The working environment is clean and not normally subject to hazardous environment or conditions.
Approximately 1-5 percent of auto travel between sites.
Travel to customers on an as needed basis.
