Manufacturing Technician I

3 weeks ago


Morrisville, North Carolina, United States Alcami Corporation Full time

Job Summary:

The Manufacturing Technician I is accountable for results in a fast-paced environment and is responsible for maintaining product quality by supporting GMP operations of life-saving sterile injectable drug products intended for clinical trials and commercial distribution.

The Manufacturing Technician I operates in alignment with established Standard Operating Procedures (SOPs) and approved Batch Records, which are developed in accordance with regulatory expectations and current Good Manufacturing Practices (cGMPs).

Responsibilities:

  • Follow established SOPs and cGMPs to execute protocols and procedures for manufacturing operations, ensuring compliance with regulatory requirements and company standards.
  • Ensure timely completion and compliance with cGMP and all other relevant company training requirements.
  • Perform manufacturing activities, including but not limited to area sanitization/cleaning, equipment preparation, dispensing, compounding, filtration, isolator aseptic filling and visual inspection.
  • Maintain unit accountability throughout manufacturing/inspection operations and provide batch yield reports to area management.
  • Perform in-process testing, weight checks, filter integrity tests, component counting and basic math calculations.
  • Manage inventory of batch consumables and finish product samples, retains and acceptable units for further processing.
  • Collaborate with cross functional teams to address quality related issues and implement process improvements.
  • Other duties as assigned.

Requirements:

  • High school diploma or GED is required. Associate or bachelor's degree preferred.
  • 0-1 years' work experience required; 1-2 years preferred.
  • Previous experience in aseptic filling or visual inspection (syringes, liquid vials or lyophilized products) is highly desirable.
  • cGMP or prior work experience in a regulated manufacturing environment preferred.
  • Prior pharmaceutical or CDMO experience required.

About Us:

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle.

At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world.

A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve.

In return, we offer challenging careers, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle.

Alcami offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision, and prescription coverage, life, LTD, STD, 401(k) with match and immediate vesting, and tuition reimbursement / student loan forgiveness.

Diversity and Inclusion:

Alcami is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.



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