QUALITY ASSOCIATE -PHARMACEUTICAL MFG.

Tower-Laboratorie; Clinton (CT); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

401(k) with company match

Tuition assistance

Flexible Spending Accounts

Life and AD&D insurances

Safety shoe and glasses reimbursements

Job summary

Tower Laboratories, Centerbrook, CT, seeks a QA Auditor on 2nd shift to enforce the quality system and ensure product integrity. You will work with production to verify that effervescent tablets and powders meet specifications in a cGMP environment.

Responsibilities include audits, investigations, document reviews, and calibration verification. A foundation in regulated industries and strong attention to detail are essential for success.

Qualifications

• Minimum of 2 years’ experience in pharmaceutical, food/beverage, nutritional supplement or another highly regulated environment.
• Demonstrated strong attention to detail.
• Knowledge of cGMP regulations highly preferred.
• Working knowledge of MS Word and MS Excel.
• Must be able to read and follow directions, complete paperwork and communicate effectively in English.
• Excellent organizational skills.
• Good interpersonal skills; ability to communicate effectively with all levels of plant personnel.
• Strong team player, demonstrated team attitude and behaviors.

Responsibilities

• Perform product manufacturing audits throughout process and conduct in-process testing to ensure specifications.
• Conduct packaging audits to ensure final product meets packaging specs and is within AQL.
• Investigate root causes when products or processes deviate from specs.
• Assist in internal audits of cGMP to ensure compliance with procedures.
• Audit finished/ batch production documents before final release by QA Manager.
• Communicate manufacturing deficiencies to relevant personnel.
• Verify instrumentation calibration and perform calibrations as needed.
• Work collaboratively with all departments to meet company objectives.
• Adhere to Safety, cGMP and company procedures.

Skills

Attention to detail

English proficiency

Team player

MS Word

MS Excel

Education

High School Diploma or equivalent; degree desirable

Tools

cGMP knowledge

Job description

Tower Laboratories is a leading effervescent product manufacturer in the U.S. We develop and manufacture over-the-counter medications, prescription pharmaceuticals, nutritional supplements, soft drink tablets and other consumer products on a contract basis. We are continually expanding our effervescent product base and currently have several new and interesting products in the research and development phase right now. We are a family owned company and have been in business for over 40 years.www.towerlabs.com .

POSITION SUMMARY

This is a 2nd shift, salary exempt position. Minimum hours will be Monday to Friday, 3:50PM to 12:20AM.

Responsible for the enforcement of Tower Laboratories, Ltd. quality system which ensures production of a consistently high quality product.

Work closely with production staff to ensure that our effervescent tablets and powders are manufactured in accordance with applicable procedures, specifications and in a cGMP (current Good Manufacturing Practices) compliant manner. Partners with manufacturing throughout production life cycle to assure that procedures are followed and activities are appropriately documented.

ESSENTIAL FUNCTIONS

• Perform product manufacturing audits throughout process through observation and by conducting in-process testing to ensure product meets specifications.
• Conduct packaging audit ensuring final product meets packaging specifications and is within the allowed accepted quality limits (AQL); inspect all incoming packaging components, ensuring specifications are met by performing appropriate tests following determined component specifications.
• Conduct investigations as directed and collect information to assess root causes when product or processes are not meeting specifications.
• Assist in the conduct of internal audits of cGMP to ensure compliance to cGMP and internal procedures and policies.
• Audit finished/completed batch production documents for procedural or mathematical errors prior to final review and release of product by the QA Manager.
• Communicate identified manufacturing deficiencies to key personnel (Machine Operator, Quality Supervisor/Manager, Production Manager, etc.).
• Verify that all instrumentation used are calibrated and perform equipment calibrations as identified.
• Work as a team member; be cooperative with all departments and staff to meet company objectives.
• Perform all work in accordance with established Safety, cGMP and company procedures.
• Other responsibilities as assigned.

ESSENTIAL SKILLS AND EXPERIENCE

• Minimum of 2 years’ experience in either pharmaceutical, food/beverage, nutritional supplement or another highly regulated environment.
• Demonstrated strong attention to detail.
• Knowledge of cGMP regulations highly preferred.
• Working knowledge of MS Word and MS Excel.
• Must be able to read and follow directions, complete paperwork and communicate effectively in English.
• Excellent organizational skills.
• Good interpersonal skills; ability to communicate effectively with all levels of plant personnel.
• Strong team player, demonstrated team attitude and behaviors.

PHYSICAL DEMANDS

• Lift, push, pull up to 25lbs. on occasional basis
• Climb stairs, walking throughout manufacturing/warehouse areas
• Must be able to wear safety shoes & safety glasses when in manufacturing/warehouse areas
• Must be able to wear sanitary attire such as gloves, hairnet, face mask and lab coat.

EDUCATION

High school diploma or equivalent; degree desirable.

This medium sized family business is headquartered in the scenic town of Centerbrook in southeastern Conn., and offers a clean, humidity & temperature controlled, friendly working environment and complete benefit package, including:

• medical
• dental
• short term and long term disability
• life and AD&D insurances
• Flexible Spending Accounts
• Health Savings Accounts
• 401(k) with company match
• tuition assistance
• free counseling with EAP
• free uniforms
• safety shoe and glasses reimbursements

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.