· At least a Bachelor’s degree, in a related field, or equivalent experience in the QA/QC field.
· Experience with FDA and international Quality Systems rules, regulations, including planning and implementation is very important.
· Excellent oral and written communication skills, strong interpersonal skills, and superior organizational abilities.
· Ability to read, write, and understand English.
· Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment essential.
· PC-based computing experience (Word, Excel, PowerPoint, Axcess). AS400 experience preferred.
· ISO 9001 Qualifications.
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 of this job.
· May work in an office environment or in the warehouse around machinery. Some occasional exposure to shop elements such as noise, moving parts, dust, and fumes. The noise level is considered usually very moderate to loud.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
· While performing the duties of this job, the employee is regularly required, for a period of 8-12 hours per day, stand, walk, sit, and use hands to handle or feel objects, controls, or tools. The employee is frequently required to talk or hear. The employee is occasionally required to reach with hands and arms and to stoop, kneel, or crouch.
· The employee must regularly lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and ability to adjust focus
This job description is not intended to be all-inclusive, but to give a guideline for the essential functions of the position. Other duties may be assigned as necessary.
Job Description :
Principle Job Function:
The Assistant QA Manager assists in conducting quality assurance audits of production facilities, ensuring company standards are maintained, and ensure project integrity is preserved. The individual appointed to this position must comply with the applicable QPSI procedures/work instructions and customer requirements. The principle responsibility of every employee is to aid in the production of superior quality products.
The Assistant QA Manager reports to the Site QA Manager and they will resolve quality, production, and efficiency problems. Functions and communicates to the QA Manager when special and quality issues occur. Suggests to QA Manager and directs activities concerned with development, application, and maintenance of quality standards for industrial and packaging processes, materials, and projects.
Principle Responsibilities/Essential Job Functions:
· Assist in training and coaching Master Leads to be proficient in their daily tasks and responsibilities. Attend all production meetings.
· Provide QA Supervisors and Master Leads with information relative to the production schedule and daily changes.
· Create batch records and specifications.
· Assist QA Supervisors and Master Leads in getting production lines running at morning start-up and immediately after each break. Checking date codes (label copy approval), proper production in conjunction with spec, inspection sheets, and material movement sheets.
· Review production rooms for outages, cleanliness, cluttered work stations, proper labeling of rejected product, quarantines product and components along with finished goods inspection.
· Audit, monitor, and evaluate Master Leads as well as QA Supervisor.
· Distribute a copy of specifications and batches for each production line/room.
· Ensure Master Leads are completing Room Clearance/Set-up Sheets. Ensure temperature and humidity gauge charts are changed and charted. Ensure finished product is within spec and meets QPSI Quality Standards as well as customer standards.
· Complete batch reconciliations and audit and review QA Coordinators/Document Control daily completion of batch reconciliations. Prepare and distribute batch records, pallet tags, labels and specifications at the start of each shift.
· Prepare and send off samples for customers. Assist in obtaining approvals for artwork.
· Assist QA Manager in conducting quality assurance audits of production facilities and assuring company standards are maintained and project integrity is preserved.
· Authority for acceptance/rejection, including release of goods.
· Other duties as assigned.