Production Associate I
Organogenesis
4 months ago
On-site
Canton, MA
Operations
What You Will Achieve
- Perform aseptic manufacturing activities for cellular based products, or production of ICL and FortaFlex Products, or HTP/collagen product activities under the direct supervision of the Manager.
- Support Manufacturing by performing tasks that ensure safe and timely product processing in cleanrooms (Class 100/ISO 5, Class 10K/ISO 7, and/or Class 100K/ISO 8).
Responsibilities
- Manufacture cellular based products per Master Batch Records and Operating Procedures under aseptic conditions.
- Perform HTP/collagen tasks (layer separation, cleaning, spreading, cutting, milling, packaging) in compliance with Quality Systems regulations and established procedures.
- Follow Operating Procedures, batch records, protocols, policies, regulatory requirements, GMPs, and safety guidelines.
- Review batch records for completeness, accuracy, and protocol compliance.
- Write deviation and corrective/preventative action reports as necessary.
- Prepare media and sanitizing agents for Production areas.
- Rinse, segregate equipment, inspect for cleanliness, run glassware washers, and prepare equipment.
- Measure/cut tubing, set up production per SOPs, wrap equipment for sterilization, and sterilize equipment.
- Run depyrogenation ovens and autoclaves.
- Follow safety policies, including bloodborne pathogen handling.
- Maintain supply inventory per production schedule.
- Operate cleanroom equipment properly.
Qualifications / Requirements
- High school diploma or equivalent (required).
- Pre-employment lift test and physical may be required for some Manufacturing positions.
Preferred Skills / Experience
- Bachelor’s degree or Biotech certificate; cGMP/quality systems knowledge; cleanroom experience.
- Aseptic Technique and cleanroom protocol experience.
- Knowledge of standard lab techniques and equipment (e.g., balances, pipettes, stir bars/bases, pH meters).
Schedule
- Sunday–Thursday or Monday–Friday shifts (approx. 7:30am–4:00pm and 6:30am–3:00pm options); some weekend/holiday work required.
- Later-shift option: 11:30am–8:00pm with some holidays; training (up to six months) is Monday–Friday 7:30am–4:00pm.
Benefits (explicitly stated)
- 401(k) with generous employer match.
- Medical, dental, and vision coverage effective on day one.
- Flexible Spending Account or Health Savings Account.
- Company-paid Short Term, Long Term, and Life insurance (plus voluntary options).
- Paid maternity leave and parental leave; adoption benefits.
- Education Assistance Policy ($5,000 per year).
- Wellness program, Employee Assistance Program.
- Generous paid time off (vacation, floating holidays, sick days, company holidays).
Application instructions
- Not specified.
- Perform aseptic manufacturing activities for cellular based products, or production of ICL and FortaFlex Products, or HTP/collagen product activities under the direct supervision of the Manager.
- Support Manufacturing by performing tasks that ensure safe and timely product processing in cleanrooms (Class 100/ISO 5, Class 10K/ISO 7, and/or Class 100K/ISO 8).
Responsibilities
- Manufacture cellular based products per Master Batch Records and Operating Procedures under aseptic conditions.
- Perform HTP/collagen tasks (layer separation, cleaning, spreading, cutting, milling, packaging) in compliance with Quality Systems regulations and established procedures.
- Follow Operating Procedures, batch records, protocols, policies, regulatory requirements, GMPs, and safety guidelines.
- Review batch records for completeness, accuracy, and protocol compliance.
- Write deviation and corrective/preventative action reports as necessary.
- Prepare media and sanitizing agents for Production areas.
- Rinse, segregate equipment, inspect for cleanliness, run glassware washers, and prepare equipment.
- Measure/cut tubing, set up production per SOPs, wrap equipment for sterilization, and sterilize equipment.
- Run depyrogenation ovens and autoclaves.
- Follow safety policies, including bloodborne pathogen handling.
- Maintain supply inventory per production schedule.
- Operate cleanroom equipment properly.
Qualifications / Requirements
- High school diploma or equivalent (required).
- Pre-employment lift test and physical may be required for some Manufacturing positions.
Preferred Skills / Experience
- Bachelor’s degree or Biotech certificate; cGMP/quality systems knowledge; cleanroom experience.
- Aseptic Technique and cleanroom protocol experience.
- Knowledge of standard lab techniques and equipment (e.g., balances, pipettes, stir bars/bases, pH meters).
Schedule
- Sunday–Thursday or Monday–Friday shifts (approx. 7:30am–4:00pm and 6:30am–3:00pm options); some weekend/holiday work required.
- Later-shift option: 11:30am–8:00pm with some holidays; training (up to six months) is Monday–Friday 7:30am–4:00pm.
Benefits (explicitly stated)
- 401(k) with generous employer match.
- Medical, dental, and vision coverage effective on day one.
- Flexible Spending Account or Health Savings Account.
- Company-paid Short Term, Long Term, and Life insurance (plus voluntary options).
- Paid maternity leave and parental leave; adoption benefits.
- Education Assistance Policy ($5,000 per year).
- Wellness program, Employee Assistance Program.
- Generous paid time off (vacation, floating holidays, sick days, company holidays).
Application instructions
- Not specified.