Essential Functions:
- Provide ethical leadership to teams to achieve production goals.
- Supervise junior operators, ensuring timely and compliant task completion.
- Monitor activities to ensure compliance with company procedures and regulatory requirements.
- Maintain audit readiness in operations.
- Guide staff in accordance with quality standards.
- Serve as a communication link between employees and management.
- Collaborate with management on work plans, task assignments, and mentoring.
- Ensure staff is knowledgeable about departmental processes and procedures.
- Observe junior team members and provide corrective feedback.
- Report inconsistencies to management and seek guidance.
- Coordinate with management to exchange ideas and review activities.
- Implement and maintain cross-training programs within teams.
- Perform procedures following SOPs, regulatory guidelines, and safety regulations.
- Conduct manipulations for product production.
- Document operations in records or log sheets according to guidelines and procedures.
- Input production data into databases.
- Assist in investigations, risk assessments, and change controls.
Additional Responsibilities:
- Supervise staff under senior management guidance, including task assignment and work planning.
- Approve time details for direct reports and manage overtime expenditures with the manager.
- Mentor and coach staff in job performance and career development, including training, feedback, and disciplinary actions.
- Contribute to the development of policies, including operational, safety, and quality programs.
- Monitor staff and workload to meet or exceed productivity standards.
- Collaborate with management to complete corrective action plans for identified deficiencies.
- Suggest and develop improvements in operating methods and procedures.
- Be present for most daily operations, covering early morning and/or closing duties.
- Perform checks to ensure quality and procedural compliance.
- Act as a technical resource for questions and issue investigations.
- Assist management in conducting performance reviews and provide regular feedback.
- Perform other duties as assigned.
Leadership Responsibilities:
- Adhere to the company's Code of Conduct and Ethics, treating people with respect and courtesy.
- Strive to make the company a great workplace, respected for its quality people and products.
- Serve as role models by acting responsibly, fairly, and honestly, exercising sound judgment in job performance.
Qualifications, Education, and Experience
Basic Qualifications:
- Bachelor’s Degree in Life Sciences or a related field with 2-4+ years of experience in a regulated environment.
- Biotechnology certificate with 4-6+ years of experience in a regulated environment, or a GED/equivalent with 8-10+ years of experience in a regulated environment.
- Proven ability to lead a team in a high-pressure, regulated production environment.
- Hands-on experience with operations in a regulated environment.
- Capable of qualifying as an On-the-Job Trainer.
- Proficient in quality management software systems.
- Solid working knowledge of MS Office (Word/Excel/PowerPoint).
Preferred Qualifications:
- Experience in a frequently audited regulated environment.
- Excellent written and verbal communication skills.
Working Conditions and Physical Demands:
- May need to sit for extended periods during operations.
- Must be able to lift, carry, push, and pull up to 50 lbs.
- Ability to work one weekend day per week.
- Rotating holiday coverage.
Job Type: Full-time
Pay: $28.00 - $29.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Vision insurance
Compensation package:
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Experience:
- Manufacturing: 1 year (Preferred)
Shift availability:
Ability to Commute:
Ability to Relocate:
- Cambridge, MA: Relocate before starting work (Required)
Work Location: In person