Supervisor, Quality - 2nd Shift

Quality Supervisor Summary 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.

General Duties and Responsibilities:

Adheres to proper cGMP's including good housekeeping, proper protection of product quality and integrity, and personal hygiene Reads and understands written instructions and SOPs Knows and understands quality-related SOP requirements that determine appropriate process for conducting job performance 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

Supervision:

Received:

Directives from Sr.

Manager, Quality Given:

Directives to

Quality Personnel Equipment:

Standard office equipment, computers, full-body suit, goggles, cap, booties, gloves, and half face-piece and full face-piece respirators.

Required Education and Capabilities:

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

Computer Skills:

Must have working knowledge of basic PC software: Excel, MS Word, PowerPoint, some form of Enterprise Resource Planning (ERP) software, etc.

Miscellaneous Requirements:

Maintain a strong attendance record 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.

Attitude:

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. The hiring range for this position in Camarillo, CA is $68,000 to $74,000 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills and experience among other factors. A bonus may be provided as part of the compensation package, in addition to a full range of other health and welfare benefits.