Associates of Cape Cod, Inc.

Celebrating 35 Years of
Testing Excellence

Associates of Cape Cod, Inc.

CAREER OPPORTUNITIES

Last Updated 07/29/2010

PRODUCTION TECHNICIANS

(posted 07/29/10)
Full time temporary workers to collect and process blood cells from Horseshoe Crabs to produce LAL-a test for a bacterial toxin. Lab experience is helpful but not required. Candidates will follow Standard Operating Procedures (SOP's) to weigh and measure manufacturing components, clean manufacturing areas, and assist in material processing. Position runs until the end of October. Must have a positive attitude, be thorough, exhibit a strong work ethic as well as participate in teams working with other group members. Must be able to lift 25 lbs.

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QUALITY CONTROL SUPERVISOR

(posted 07/22/10)
Candidate will be responsible for the review, interpretation and trending of data from chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples in accordance with current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Candidate will schedule all group activities, personnel management, training and support, and coordinate testing priorities with other departments. Candidate will also conduct performance management and development, including performance reviews and objectives, interviewing and hiring. Bachelor's degree in related science field with 6+ years of experience in the medical device, biotech or pharmaceutical industry, advanced degree preferred. At least 4 years of supervisory experience preferred.

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SENIOR RESEARCH SCIENTIST

(posted 07/15/10)
Candidate will develop a scientific understanding of the Company's product line and effect changes in protocols to give greater reliability with respect to products, and develop new products which center on the current technology and develop new concepts leading to new assay technologies. Provide technical expertise to conceptualize and implement new research areas, provide technical support when necessary and supervise the Research and Development staff. Candidate will have postdoctoral experience in enzymology and assay development, 2 to 5 years research experience in assay development technologies along with experience working in a GMP environment. Skills required: protein synthesis, labeling and purification, enzyme assay development, carbohydrate analysis, Real Time PCR, instrumentation: spectral techniques, surface Plasmon resonance, and fluorescence polarization. Education: Ph.D. in Chemistry or Biochemistry.

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FACILITY MECHANIC

(posted 06/15/10)
Candidate will be responsible for monitoring Process and Utility systems and equipment to ensure efficient operations, perform scheduled and corrective maintenance of Purified Water, Clean Steam, WFI and Process Gasses. Maintain critical facility utilities such as boilers and steam distribution systems, air compressors and other utilities. Troubleshoots and repairs electromechanical equipment of all types, including HVAC systems. Ensures compliance with quality system procedures related to the Facility equipment. Evaluates equipment performance and recommends improvements, maintain and monitor facilities boiler with the Code of Mass. Regulations CMR-146. Associates degree or equivalent education from a technical trade school and five or more years field experience which includes electrical and mechanical troubleshooting and repair. Universal refrigeration license and prior life science industry experience is preferred. Must be able to obtain a MA Second Class Fireman's License or Special License to Operate within a one year period.

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DIRECTOR OF QUALITY

(posted 05/12/10)
The Director of Quality is responsible for ensuring that personnel, methods, corporate policies and standard operating procedures comply with cGMP, ISO 13485 and other applicable national and global requirements.

GENERAL RESPONSIBILITIES:

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;
Develop and implement GMP and ISO training programs throughout the company;
As process owner, and 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

KNOWLEDGE AND SKILL REQUIREMENTS:

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

EDUCATION AND EXPERIENCE:
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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TECHNICAL SALES SPECIALIST - NORTHWEST TERRITORY

(posted 05/4/10)
Candidate will be responsible for selling Associates of Cape Cod Inc.'s products and services in the assigned territory. Responsible for key account management and new account development within specified region, growing the Company revenue through field sales calls and phone sales calls managing accounts in a large geographical area. Will also perform presentations and workshop instruction, train clients in all instrumentation and LAL methods, and attend national and customer meetings and vendor shows. Must have the ability to travel greater than 50% of the time and possess a valid driver's license. Candidate will be required to use personal vehicle for making local sales calls. Must possess excellent oral and written communication skills, be a self starter, demonstrate good business judgment, possess a good working knowledge of MS Word, Excel and PowerPoint and the ability to close new accounts. A college degree, preferably in a life science discipline is required along with two years of technical sales experience in the biotech, medical device or pharmaceutical industry with a proven sales history of growth and success.

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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