Document Control Specialist

Associates of Cape Cod Inc.; East Falmouth (MA); On-site; USD 54,000 - 62,000; Full time

Benefits offered by this job

401(k)

Dental insurance

Health insurance

Paid time off

Tuition reimbursement

Flexible schedule

Job summary

Associates of Cape Cod, Inc. (ACC) is seeking a Document Control professional to maintain and supervise controlled documents, logs, and archival processes in a GMP/ISO environment.

The role supports audits, training, and monthly quality reports while ensuring records are accurate and accessible. The position requires knowledge of cGMP and ISO 13485, an associate degree, and 1–3 years in FDA/ISO-regulated settings.

Qualifications

• Experience in cGMP and ISO 13485 document control is required.
• Detail oriented with strong organization and time management.
• Ability to collaborate in a fast paced team environment and meet deadlines.

Responsibilities

• Maintain all Document Control procedures and update activities.
• Manage document control databases and logs for accuracy.
• Maintain distribution logs and ensure proper issuance of controlled docs.
• Archive storage, retrieval, and offsite storage coordination.
• Prepare and release item masters and batch documentation as needed.
• Support audits, training, and monthly reporting related to Document Control.
• Assist in CTS reports and other Quality System assignments.

Skills

cGMP knowledge

ISO 13485

Document control

Detail oriented

Organizational skills

Multitasking

Communication skills

MS Office proficiency

Education

Associate degree or equivalent

1–3 years FDA/ISO regulated experience

Job description

About the Organization Associates of Cape Cod, Inc. (ACC) Your Endotoxin Experts! Manufactures bacterial endotoxin and beta-glucan detection products. The Company offers enzymes, muco-polysaccharides, monoclonal antibodies and glyco-conjugates, endoglycosidases, and exo-glycosidases, as well as limulus amebocyte lysate products. ACC serves customers worldwide.

Description

PURPOSE: Maintain Document Control systems and activities in compliance with ACC policies and procedures, QSRs and 13485

GENERAL RESPONSIBILITIES:

• Maintain all Document Control procedures in an updated and accurate manner and implement all activities as required;
• Maintain Document Control databases and logs such that they are up to date, efficient, and accurate at all times;
• Maintain distribution logs for controlled documents in Electronic Document Management System or other logs as appropriate;
• Ensure that controlled documents are kept up to date and issued as appropriate, and superseded documents are retrieved to prevent inadvertent use;
• Maintain and control archive storage locations such that they are kept up to date and organized for ease of retrieval of records, and in a manner that prevents damage and misuse. Scan records as appropriate;
• Organize and log records to be sent for offsite storage, and communicate with supplier when retrieval is needed;
• Follow Record Retention procedures and ensure shredding is documented as appropriate and includes the required approvals;
• Maintain accountability for issuance and verification of control numbers (i.e. lot numbers) per procedures;
• Prepare documents for use in a timely manner such as Production binders (PHR's), in-process paperwork, kitting and packaging requests, etc;
• Review and release Item Masters into GP;
• Enter lot information into the Labeling databases per procedures;
• Maintain Level 0 Documents (regulatory standards, guidance's, etc) per procedures and ensure logs and review forms are completed;
• Scan and upload certificates of analysis and certificates of compliance for Customer Service and website as appropriate, per procedures;
• Author, review, process and close document changes in a timely manner, ensuring compliance with applicable procedures;
• Participate in training related activities, including but not limited to LMS administration activities, conducting training, and participating in assigned training;
• Participate in and complete all projects and Quality System assignments in a timely manner and to meet the requirements of the procedures;
• Maintain and support administration of systems and services utilized by Document Control including but not limited to GMP training, Standard subscriptions, and Shredding services.
• Support generation of monthly reports;
• Support and prioritize all Document Control related activities and requests for records;
• Prepare for, support, and participate in customer, regulatory, and internal audits;
• Support software media production and MD5 verification activities;
• Review and approve CTS reports as a backup, as required; and
• Other duties as assigned.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Working knowledge of cGMP, ISO 13485 and principles of document control.
• Detail oriented and excellent organizational skills.
• Ability to work in a fast paced team environment.
• Ability to work on multiple tasks and meet deadlines.
• Excellent oral and written communication skills.
• Proficiency in all office based software.

EDUCATION AND EXPERIENCE:

• A minimum of an Associates Degree or equivalent combination of experience and/or education required.
• Minimum of 1-3 years experience working in an FDA and/or ISO regulated environment or equivalent combination of experience and/or education required.

GENERAL COMPETENCIES:

• Communicates well (written and verbal), delivers presentations, has good listening skills
• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held.
• Good listener, committed to finding solutions to problems, works well with difficult people
• Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers.
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record.
• Honest, accountable, maintains confidentiality.
• Information, organized and accessible, maintains efficient work space, manages time well.
• Pursues everything with energy, drive, and a need to finish; seldom gives up before finishing, especially in the face of resistance or setbacks.
• Manages workload, works efficiently, and meets goals and objectives.
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements.

PHYSICAL REQUIREMENTS:

Constantly sit, occasionally stand, frequently walk, occasionally use hands to finger, handle, or feel. Constantly reach with hands or arms, climb or balance, stoop or kneel, crouch or crawl. Constantly talk or listen. Lift 11-25 lbs 1-33% of the time. Carry 11-25lbs 1-33% of the time. Occasionally exposed to toxic or caustic chemicals. The work environment is typically quiet for this job.

SALARY: $54,000-$61,500 annually

PAY RANGE DETAILS

The pay range listed on each job posting at acc represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate's work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.

BENEFITS:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

Full-Time/Part-Time Full-Time

This position is currently accepting applications.