Associates of Cape Cod, Inc.
Celebrating 35 Years of
Testing Excellence
Testing Excellence
Associates of Cape Cod, Inc.
CAREER OPPORTUNITIES
Last Updated 05/17/12
PRODUCTION TECHNICIAN
(posted 05/08/12)Candidate will perform prep work, manufacturing, and assembly duties for the production of ACC and SKK products. Weigh, measure, and check raw materials to assure batches manufactured contain the proper ingredients and quantities. Will work with filling and crimping machines routinely. Must be able to work in teams comprised of immediate group members. High school diploma is required. Previous manufacturing experience is preferred. Must be able to lift a minimum of 25 lbs.
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DIRECTOR OF FINANCE
(posted 04/25/12)This position is responsible for directing and coordinating the Company's financial accounting, reporting, auditing, systems development and revenue/cash management. Candidate must have strong leadership abilities, possess established skills in cost and process accounting, short/long-term financial planning and budgeting, and financial reporting and analysis. Minimum of 10 years progressive experience in accounting and general financial management in a technology oriented manufacturing environment, with international reporting experience required. An M.B.A.. Master's in Finance or CPA is preferred, or equivalent combination of education and experience.
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TESTING SERVICES LABORATORY ANALYST
(posted 04/06/12)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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QUALITY CONTROL INVESTIGATOR
(posted 03/08/12)Candidate will independently lead and coordinate investigations in the Quality Control laboratory, with the main focus on OOS (out of specification) investigations. Candidate will investigate the excursion in collaboration with Quality Control Analyst, perform investigative testing, and document results. Candidate must possess strong technical writing skills, have a working knowledge of cGMP quality system requirements and principles of quality control, and have strong problem solving skills. Candidate must be able to work independently and with others, as investigations will require cross functional departmental involvement. Must be detail-oriented, possess a strong work ethic and have a proven track record of managing multiple priorities and deadlines. Bachelor's degree in a relevant scientific discipline is required. Experience in conducting root cause analysis and proficiency in MS Word and Excel is also required. Five or more years of previous laboratory experience is 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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Associates of Cape Cod, Inc. is an Equal Opportunity Employer.