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Leiters Health · 3 weeks ago

Quality Supervisor (3rd Shift)

Denver Metropolitan Area

Full-time

Onsite

Entry, Mid Level

$74K/yr - $92K/yr

1+ years exp

Leiters Health is a pioneering company in the pharmaceutical industry dedicated to delivering high-quality compounded sterile products. The Quality Supervisor will evaluate and monitor quality assurance activities to ensure compliance with cGMP requirements and maintain product quality and safety.

Health CarePharmaceutical

H1B Sponsor Likely

Responsibilities

Evaluate completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately, and acceptance criteria met

Draft, review or approve sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures

Evaluate and write validation protocols including commercial batch and stability test methods as well as sterilization techniques for consumables, containers and finished drug products. Also, provide support to equipment validation and subsequent quality dispositioning

Review and approve criteria for analyses carried out under contract through private labs. Ensure that the appropriate validations, including those of analytical procedures, and calibration of control equipment are performed

Review and approve maintenance activities for processes and equipment

Ensure that the required initial and continuing training of personnel is carried out and adapted according to need

Review and approve investigations of reprocessing/rework of products, complaints, analytical failures, and returns/salvages

Classify, file, audit, receive, distribute, track and maintain system of classified and unclassified company documents according to established procedures and standards for security and document organization

Supporting or performing internal audits

Supporting external regulatory or customer audits

Gather information from multiple departments for trending and presentation to management

Identify trends in the industry and recommend improvements

Work with a team to ensure that the systems involved in an outsourcing facility are in a state of control

Other duties as assigned

Foster a positive and productive work environment, providing guidance, coaching, and mentoring

Conduct regular 1:1’s to address performance, feedback and relationship building

Identify training and development needs within the team and facilitate as able

Qualification

CGMP knowledgeQuality AssuranceSupervisory experienceAnalytical skillsMicrosoft OfficeAttention to detailCommunication skillsTeamwork

Required

Bachelor's Degree (Science discipline preferred) and/or commensurate experience required

1-3 years of experience in supervising in a cGMP FDA regulated pharmaceutical manufacturing environment

Knowledge of cGMP guidelines/standards and ability to identify potential adverse issues

Able to work in a fast-paced environment and adaptable to change

Demonstrated written and oral communications skills including strong presentation skills

Strong results orientation and attention to detail

Strong Microsoft Office skills are essential, proficient in the use of spreadsheets and word processing programs

Must pass English Competency Test

Benefits

Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!

Flexible Spending & Health Savings Accounts (FSA & HSA) available

Dental & Vision insurance

Employer Paid Life Insurance & Employee Assistance Program

Short Term & Long-Term Disability Insurance

Up to 4% 401K Matching (100% vested on day one!)

Generous Paid Time Off Options – vacation, sick , paid leave and holidays!

$5,250 Annual Tuition Reimbursement after 6 months

$1,000 Referral Bonus Program with no limit

Eligible for annual bonus program

Company

Leiters Health

Leiters Health is a trusted FDA-registered 503B outsourcing provider of high-quality compounded sterile preparations and pharmacy services.

Founded in 1926

Englewood, Colorado, USA

201-500 employees

https://leiters.com/

H1B Sponsorship

Leiters Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2024 (1)