Supervisor, Quality - 2nd Shift

GSMS•Camarillo, CA

2d•Onsite

About The Position

The Quality Supervisor will plan, coordinate, and direct quality programs designed to ensure continuous production of products consistent with established standards. The Quality Supervisor will ensure suitability and effectiveness of GSMS product quality and compliance with all applicable domestic and international regulations, directives, and standards.

Requirements

Three to five years in pharmaceutical manufacturing preferred
Knowledge of federal and state laws and regulations, and accreditation standards
The ability to conceptualize, plan, and execute compliance audits, and prepare reports of audit findings for senior management, is required
Through knowledge of quality system regulations/requirements (i.e. ISO – International Organization for Standardization, FDA – Food and Drug Administration, and GMP – Good Manufacturing Practices
Knowledge of manufacturing processes
Effective communication skills at all levels both written and verbal
Effective skills in analytical thinking and problem solving
Ability to perform multiple tasks and ability to effectively manage conflict
Ability to work in teams to obtain results
Must be a self-starter than can work independently on assigned projects and know how to ask for help when needed
Can effectively cope with change and is comfortable shifting direction
Time management and planning skills are essential, as well as excellent interpersonal skills in order for the incumbent to work effectively with auditees and assure timely implementation of corrective measures following audits
Excellent computer skills and strong internet research skills is required
Job involves extensive periods of sitting, a lot of reading and analyzing of information
Must have the ability to adapt work through conflicts and persuasively influence outcomes
Can effectively cope with change and is comfortable changing direction and acting without complete information
Ability to develop and deliver effective presentations and written/oral communications.
Strong organizational and prioritization skills
Team player works with others effectively respectfully and cordially
Executes plans to resolve basic to moderately complex problems
Capable of resolving sensitive concerns that present minimal risk to the business
May be required to work longer than the typical 8-hour workday
Regularly required to stand; walk; use hands to fingers, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl
Frequently required to sit
Specific vision abilities required includes close vision, distance vision, color vision, peripheral vision, depth vision, depth perception, and ability to adjust focus
Perform light physical duties in keeping personal workstation clean organized, and presentable
Must have working knowledge of basic PC software: Excel, MS Word, PowerPoint, some form of Enterprise Resource Planning (ERP) software, etc.
Must be able to pass screening, drug test and background check.
Adhere to company’s drug-free workplace policies.
Knowledge of computer equipment set-up.
Skill in using precision tools.
Must be able to effectively research, compile, sort, and present information and reports.
Individual must be enthusiastic, concerned with job and company as whole, openness with management, and punctual.
Strong communication skills.
Self-discipline and a desire to achieve results.
Must be flexible.
Must be detail oriented.
Team player, professional, and achieve high quality results.

Nice To Haves

Must have the ability to adapt work through conflicts and persuasively influence outcomes
Can effectively cope with change and is comfortable changing direction and acting without complete information
Ability to develop and deliver effective presentations and written/oral communications.
Strong organizational and prioritization skills
Team player works with others effectively respectfully and cordially
Executes plans to resolve basic to moderately complex problems
Capable of resolving sensitive concerns that present minimal risk to the business
May be required to work longer than the typical 8-hour workday
Regularly required to stand; walk; use hands to fingers, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl
Frequently required to sit
Specific vision abilities required includes close vision, distance vision, color vision, peripheral vision, depth vision, depth perception, and ability to adjust focus
Perform light physical duties in keeping personal workstation clean organized, and presentable
Must have working knowledge of basic PC software: Excel, MS Word, PowerPoint, some form of Enterprise Resource Planning (ERP) software, etc.
Must be able to pass screening, drug test and background check.
Adhere to company’s drug-free workplace policies.
Knowledge of computer equipment set-up.
Skill in using precision tools.
Must be able to effectively research, compile, sort, and present information and reports.
Individual must be enthusiastic, concerned with job and company as whole, openness with management, and punctual.
Strong communication skills.
Self-discipline and a desire to achieve results.
Must be flexible.
Must be detail oriented.
Team player, professional, and achieve high quality results.

Responsibilities

Plans and schedules the work of Quality Inspectors; ensures that all inspection and test procedures are properly completed and documented
Reviews all quality assessment results and determines whether to accept or reject manufactured products during the inspection process; coordinates activities that support the timely release of products according to schedule
Works closely with Operations management to ensure adequacy and appropriateness of inspection parameters, product specifications, and test methods
Evaluates new materials and products to assure compliance criteria
Prepares daily reports, monthly, and quarterly summaries on quality indicators as required
Develops and maintains inspection documentation procedures and ensures product compliance regulations are followed
Provides quality related data, recognizes trends in data, and reports both to upper management; Tracks average number of defects per million units inspected as a process average for all product lines
Supports customer complaint responses; Support the Tier I and Tier II CAPA processes
Directly supervises Quality Inspectors, Logistics, and Leads who are responsible for ensuring quality on the manufacturing lines
Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws
Additional responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems