About Us

We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions.  Our strength is giving others strength.

Learn more about Careers at Organogenesis

What You Will Achieve:

This position is responsible for the day to day operation of the Document Control function.  Incumbent is responsible for change incorporation, master filing activities and change administration requirements for product documentation and labeling.  Device Master Record and Device History Record file maintenance.  In addition, performs process improvements within the Document Control Area.

How You Will Achieve It:

• Prepares CO packets for review, tracks COs through the review and approval process and coordinates incorporation of approved changes.  Incorporates approved changes / “redlines” to documentation.  Supports Change Control System metrics to allow for monitoring of trends, etc.
• Administration and Maintenance of the Quality System documents – Ensures authorizations are maintained for Change Control Board (CCB).  Maintains change/revision history, Device History and Device Master Records, Area Reference copies, Oversees Periodic Review documentation, filing and archiving activities.  Manages Off-Site Storage Program.
• Master Filing – Produces “original” documentation, verifies the correct incorporation of changes, updates Device Master Record as applicable and verifies master filing activities.
• Customer Service Activities – Interdepartmental copy requests, internal customer inquiries, expedition of interdepartmental copy requests, support interdepartmental research / investigation activities.
• Collaborate with different members of the QA department working in special projects and additional assignments as directed by Supervisor.

Requirements

What You Need to Achieve It:

• Required Education: BS in a relevant scientific discipline (Chemistry, Biology, Biochemistry)
• Work Experience: 2-5  years of experience in a cGMP Quality Control department in a FDA regulated industry.
• Requires strong personal computer skills Keyboarding, Microsoft Office Applications (Access, Excel and Word).  Knowledge of Auto-CAD desirable.
• Must be detailed oriented, be able to follow detailed instructions, possess excellent time management skills, be well organized, a self starter and display a professional demeanor with a high focus on customer service activities / responsibilities.
• Ability to follow through and consistently demonstrate that all primary job duties and responsibilities are current and up to date; ability to closely monitor and communicate progress on daily tasks and responsibilities to Management.
• Must be able to work as a team member, maintaining day to day activities while being responsive to changing priorities.
• Must have strong customer service skills.
• Verbal communication skills (English)
• Knowledge of Good Manufacturing Practices / Quality System Regulations and ISO Standards required.
• Must be able to work a consistent schedule to satisfy the Customer Service responsibilities of the job.
• In depth knowledge of electronic document control systems.

The anticipated annualized base salary for this role is $70,000-$87,500 and reflects current market data for similarly-sized life science companies and internal equity.  Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law.

What can we offer you?

• 401k -- generous employer match with immediate vesting and financial planning resources
• Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
• Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
• Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
• Paid maternity leave and parental leave for all new parents
• Adoption benefits
• Education Assistance Policy - $5,000 per year for all employees
• Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
• Employee Assistance Program
• Generous paid time off including vacation, floating holidays, sick days, and company holidays
• Free parking including an electric charging station (Canton and La Jolla0

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

We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.