Associates of Cape Cod, Inc.

Celebrating 35 Years of
Testing Excellence

Associates of Cape Cod, Inc.

CAREER OPPORTUNITIES

Last Updated 01/11/12

CTS ANALYST

(posted 01/11/12)
Candidate performs Bacterial Endotoxin Test and/or method development/validation on samples received in the laboratory based on USP standards, current Good Manufacturing Practices (cGMP) and Associates of Cape Cod Inc.'s Standard Operating Procedures. Perform testing using each of the three LAL (limulus amebocyte lysate) methods, (gel clot, turbidimetric and chromogenic), interpret results, perform pipetting, report writing, interact with clients relative to sample testing, database entry, utilize calibrated/certified equipment & instrumentation, and maintain certification in all three LAL methods. 3-4 years experience in a laboratory environment, Bachelor's degree in biochemistry, chemistry or biology, strong organizational skills, must be detail oriented with good aseptic/laboratory technique, possess the ability to work independently as well as with others in a fast paced environment, excellent oral and written communication skills, possess a working knowledge of cGMP, ISO 9001, ISO 13485 and internal operating procedures. Will be required to pass a pipetting proficiency training and certification course and obtain or have obtained Hepatitis B vaccination.

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WAREHOUSE SUPERVISOR

(posted 12/15/11)
The candidate will receive materials for use in ongoing business activities, and supervise warehouse staff. Responsible for the receipt of all incoming freight and the accurate entering into the Data Management System (DMS), along with maintaining accurate inventory level. Maintain an orderly and systematic raw material warehouse per current Good Manufacturing Practices (cGMP) and company procedures. Ensure compliance of quality and safety standards (OSHA), and provide for training of warehouse personnel. Work with Materials group in the cycle count program to support the accuracy of inventory, investigation and resolution of all inventory discrepancies. Assist in physical inventory counts. Participate in customer audits as it relates to the Receiving process. 4 years previous experience managing shipping/receiving/warehousing functions, along with previous experience working in a cGMP/ISO regulated environment. Proven record of excellent leadership, organizational management, and communication skills. Possess strong decision making skills with the ability to manage and resolve critical business issues. Strong knowledge of MS Office applications-Word, Excel and Outlook.

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QUALITY ASSURANCE ENGINEER/SENIOR QUALITY ASSURANCE ENGINEER

(posted 05/16/11)
This position, reporting to the Director of Quality, is focused on Quality Systems and their management and improvement. Process owner for Risk Management creating and applying policies and procedures for identifying, analyzing and controlling risk throughout the product life cycle. Ensure compliance within the Quality System Elements as they apply to the QSR's, while being a strong advocate for efficiency and adding value to the business. Understanding the best methods and being able to provide a wide range of recommendations to the teams as they work within the different Quality System Elements, such as Design/Design Transfer, Production Controls, Investigative Process Flow & Documentation within the CAPA System, Complaint and Non-Conforming Material Systems, etc. Responsible for coordinating investigations from a project management standpoint.

5+ years experience in an ISO/FDA regulated industry, 5+ years of managerial experience, working knowledge of ISO 9001, ISO 13485:2003 and 21 CFR Part 820 regulations, high attention to detail, excellent organizational, written and oral communication skills, able to work in a fast-paced environment, possess a high degree of critical thinking skills. Bachelor's degree in life science and 5+ years experience in bio-tech or pharmaceutical industry preferred.

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DIRECTOR OF QUALITY

(posted 05/16/11)
The Director of Quality is responsible for ensuring that personnel, methods, corporate polices and standard operating procedures comply with cGMP, ISO 13485 and other applicable national and global requirements. Participate in formulating and administering company policies and procedures and development of long-range quality system goals and objectives; establish, implement and effectively maintain a quality management system that complies with the Food and Drug Administration, Current Good Manufacturing Practices and ISO 13485 requirements; ensure and promote awareness of regulations and customer requirements throughout the organization; stay apprised of the latest regulatory requirements as they relate to the quality management system and implement the necessary policies and procedures to ensure compliance; review and monitor compliance of the established quality system to determine where improvements are needed and implement appropriate corrective and preventive actions; report on the performance of the quality management system to management, including any need for improvement; participate in product development and process improvement team activities; oversee document control, quality control, internal quality auditing, complaint handling, customer audits, supplier programs, product release and other quality system activities; evelop and implement GMP and ISO training programs throughout the company; key implementer of the Quality Plan, ensures that the metric reporting requirements are met in timing and quality; carry out supervisory responsibilities including interviewing, hiring, and training employees, planning, assigning, and directing work, appraising performance and resolving problems; and other duties as assigned. The successful candidate must possess excellent knowledge of cGMP, ISO 9001, ISO 13485 and quality system requirements; detail oriented and excellent organizational skills; able to work in a fast paced team environment; excellent oral and written communication skills; strong management and training skills.

A Bachelor's degree in a scientific or health care discipline required, Masters level preferred. Must have experience with quality control methods and quality assurance systems. Must have at least 10 years experience in the medical device, biotech or pharmaceutical industry, and seven of them in quality. Must have at least five years management experience.

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Fax resume to (508)444-1480, Attn: Human Resources.
Or mail to: Associates of Cape Cod, Inc., Attn: Human Resources
124 Bernard E. Saint Jean Drive, East Falmouth, MA 02536