Quality Technican

SUMMARY:

The Quality Technician will be responsible for executing a wide range of quality control activities to ensure that all products meet the stringent standards required in a 503b outsourcing facility. This position requires hands-on involvement in the inspection, testing, and documentation processes, working closely with the Quality Manager to maintain compliance with regulatory standards.

DUTIES AND RESPONSIBILITIES:

• Perform detailed inspections of raw materials, in-process products, and finished goods to ensure they meet established quality criteria.

• Assist in the preparation, review, and maintenance of batch records and Standard Operating Procedures (SOPs) to ensure accuracy and adherence to cGMP guidelines.

• Carry out sampling and laboratory testing of products, including sterility and potency tests, to confirm that they meet all required specifications.

• Collaborate in investigations of product deviations and non-conformities, assisting in the development and implementation of corrective actions.

• Maintain meticulous records of all quality control processes, ensuring that documentation is complete and compliant with regulatory requirements.

• Support the calibration, maintenance, and validation of laboratory equipment to ensure consistent and reliable performance.

• Assist in the preparation for regulatory audits and inspections by providing accurate documentation and responding to inquiries.

SUPERVISORY RESPONSIBILITIES:

• N/A

QUALIFICATIONS:

• Associate’s degree or equivalent in Chemistry, Biology, or a related field.

• At least 2 years of experience in quality control within a pharmaceutical, biotech, 503B outsourcing facility, or similar regulated environment.

• Familiarity with cGMP regulations and quality control methodologies.

• Strong attention to detail, problem-solving skills, and ability to work effectively both independently and within a team.

• Excellent written and oral communication and interpersonal skills

• Experience in Quality administered systems (e.g LIMS, QTS, eQMS, SAP, DMS) preferred

• Previous experience with a startup facility and developing Quality Operations processes is beneficial.

• Preferred experience with sterile drug production, aseptic practices, and investigations

• Proficiency in MS Word (advanced editing skills) and MS Excel

• Flexibility and adaptability in day-to-day activities to support a dynamic and developing production site.

• Ability to carry out detailed written or oral instructions.

COMPETENCIES:

• Oral Communication--Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.

• Written Communication--Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.

• Change Management—Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.

• Quality Management--Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• Continually required to stand

• Continually required to walk

• Continually required to sit

• Occasionally required to carry items less than 25 pounds

Job Type: Full-time

Pay: $50,000.00 - $60,000.00 per year

Experience:

• Quality control: 2 years (Preferred)

Shift availability:

• Day Shift (Preferred)

Ability to Commute:

• Sugar Land, TX 77478 (Required)

Ability to Relocate:

• Sugar Land, TX 77478: Relocate before starting work (Required)

Work Location: In person

Salary : $50,000 - $60,000