Sr. QC Specialist

Job Description

Job Description

Salary : $33-35 / hour

Summary

The Sr. Quality Control Specialist works under the general direction of Head of Quality as the lead for Quality Control laboratory.

The primary responsibilities are : timely disposition of Raw Materials, In-Process and Customer Supplied Bulks and efficient operation of Quality Control laboratory.

Essential Responsibilities

Help Develop, implement and maintain QC systems and measures

• Inspect and test Raw Materials, Fragrances, In-Process and Customer supplied bulk, against specification to ensure quality standards are met.
• Establish priorities to ensure timely job completion.
• Issue adjustments to In-Process Bulk if necessary
• Complete Inspections forms for Finished Bulk / Intermediate and / or Raw Materials and Fragrances.
• Update status of Raw Materials and / or Bulk / Intermediate in ERP system
• Communicate quality control information to all relevant organizational departments, outside vendors or contractors
• Produce and communicate reports regarding nonconformance of products
• Assist in investigations related to Nonconformance or OOS, Customer Complaint
• Provide Department related data, trends etc. for Management Review
• Resolve production and manufacturing problems to minimize cost and delay
• Maintain the raw material retains for the Department
• Maintain all Quality Systems logs related to the Department
• Monitor Performance of QC systems to ensure effectiveness, efficiency and compliance to company SOPs and regulatory requirements
• Assist in updating or writing Department related SOPs and Work Instructions or other Department related documents.
• Review statistical studies, technological advances or regulatory standards and trends to stay abreast of issues in the field of quality control
• Identify and implement training needs for the production team to meet quality standards
• Instruct staff in QC and analytical procedures
• Assist in Raw Materials and Bulk / Intermediate Cycle Counts and Full Inventories
• Consistently demonstrates excellent interpersonal skills and professionalism to company management, all levels of staff and vendors and outside agencies

Qualifications

To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description.

The requirements listed below are representative of the knowledge, skills and / or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• Discretion in handling confidential and sensitive matters
• Knowledge of drug cGMPs, SOPs and regulatory guidelines including FDA requirements

Education, Experience and Licensure

• Bachelor’s degree in science (chemistry, pharmacy, or biology) or equivalent work experience.
• 5+ years Quality Control related experience in a cGMP OTC manufacturing environment.

Skills

• Proficient use of Microsoft Office products including Word, Excel, Outlook and PowerPoint.
• Experience using common laboratory equipment such as pH Meter; Refractive Index; Pycnometer; Brookfield Viscometer; Color Matching;

Scales; and lab mixers

• Must be able to clearly and concisely communicate verbally and in writing in English
• Ability to speak and understand Spanish is a plus
• Must be able to analyze and present quantitative data.
• Able to accurately compute basic mathematical equations such as addition, subtraction, division, multiplication and percentages

Reasoning Ability

Must be able to analyze and interpret data relating to various projects and resolve issues and problems that arise including :

• Resolve issues of a general, routine and complex nature and exercise appropriate judgment to escalate issues to senior management.
• Effectively prioritize routine and non-routine work assignments to ensure goals and timelines are met.
• Apply knowledge of Quality Control best practices, cGMPs, regulations, and Company policies to problems and provide appropriate resolution.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job.

• Must have good visual / organoleptic alertness.
• Must be able to sit for up to eight hours per day, lift and carry up to 20 lbs with or without assistance, reach above shoulder height, bend, stoop, and crawl to retrieve items from under a desk or floor level cabinet or drawer;

push and pull, use a computer keyboard throughout the workday, stand while filing or performing other essential responsibilities.

Exposure to standard chemicals used in an office environment is expected and includes but is not limited to toner, glue and liquid paper or white out.

Additionally, the incumbent will be exposed to chemicals used in the manufacturing process of nutritional supplements, cosmetics, and prescription drugs.

Must have reliable transportation and valid driver’s license and be able to drive to appointments. Must maintain current, in-force vehicle insurance.

Local candidates only. No Recruiters please.