Quality Assurance Training Specialist

Sharp Packaging Services•Allentown, PA

1d•Onsite

About The Position

This position will be responsible for the design and implementation of GMP training curriculum(s) for designated areas within Sharp Commercial US. Key responsibilities include adherence to and enforcement of GMP compliance, training of designated peers at management request, managing the Sharp Commercial - US GMP training program, providing hands-on and on-the-job training, maintaining training documents, and ensuring training records are up-to-date and ready for regulatory inspections. The training provided by this role has a direct impact on the company's compliance with regulatory requirements and customer satisfaction.

Requirements

Associate or bachelor’s degree is preferred with one to four years related experience, a minimum of (2) Certificates of basic quality skills and practices and/or training or a High School Degree with four to six years related experience and/or training.
Experience in inspection of Pharmaceutical or related industry is required.
Good Documentation Practices Skills.
Demonstrated ability to design training materials and deliver interactive training.
Excellent verbal and written skills.
Ability to simultaneously manage multiple tasks.
Ability to work flexible hours.
A positive work attitude that supports teamwork and continuous improvement.
Excellent interpersonal communication skills and presentation skills with personnel from multiple departments and responsibility levels.
Equipment and Tooling Identification.
Proper Calibration Status.
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.
Ability to effectively communicate (written or verbally) with Quality Department and Operations Department employees for information on training related issues and cGMP issues.
Ability to provide clear, concise, and legible documentation within the batch record and/or memos to file in conformance with basic Good Documentation Practices.
The ability to make rational decisions pertaining to quality compliance is required.
Ability to resolve problems effectively and efficiently.
Basic Windows applications include Microsoft Office Suite.

Nice To Haves

Associate or bachelor’s degree.
Outside certification of basic quality skills and practices (i.e. ASQ, CQIA, CQI, CQT, etc.).

Responsibilities

Responsible to work with designated areas(s) to identify critical job roles and/or tasks requiring training.
Design curriculums for identified roles, define training requirements for each curriculum and design qualification requirements, criteria, and assessments for associated curriculums.
Perform administrative tasks within the QMS for the training module (including but not limited to assigning learner roles, adding or removing items from learner roles, creating training requirements, etc.).
Work with other training specialists to develop processes and best practices for managing the GMP training program.
Work with the training specialist to develop process and best practices for maintenance and update of the GMP training program for new and existing staff according to cGMP’s and Sharp procedures.
Phase I Orientation which includes but is not limited to: SOP Training, Facility Tour, Proficiency Training.
Phase II Training which includes but it not limited to: SOP Training, Proficiency Training.
Qualifications which include, but are not limited to: Staging Verification, AQL Verification and Label Verification, Cleaning Verification, Reconciliation, Calculations.
Responsible for maintaining Training program and training records in an inspection ready state.
Responsible for identifying training gaps through critical review and assessment of current training processes for effectiveness and making modifications to training curriculum and qualification requirements to improve demonstrated effectiveness.
Responsible for providing periodic training status updates and reports.
Responsible for coordinating internal meetings/training with Supervisors.
Must be flexible to meet the needs of the organization relative to off shift training when required.