Quality Supervisor (3rd Shift)

Leiters Inc•Englewood, CO

14h

About The Position

This position will report to the Quality Assurance (QA) Manager. The Quality Supervisor evaluates, tracks, trends, and monitors the Quality Assurance and Quality Control activities in an outsourcing facility.   The position is responsible for the assurance that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements.   The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance, attention to detail, and excellent communication with other functional areas and sites. Moreover, the role is responsible for promoting our mission of improving patient outcomes with high quality outsourced pharmaceuticals.

Requirements

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

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.

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