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Job Summary:
STAQ Pharma is a 503B Outsourcing Facility located in Denver, Colorado. STAQ Pharma produces sterile injectable medications for adults and pediatric patients, compounded under cGMP standards. STAQ’s ownership and board are composed of large hospital systems ensuring the priority focus remains on delivering needed medications in a safe and timely manner. We are looking for exception people to join the STAQ team.
This role is responsible for leading all Quality Control (QC) activities at the site. The QC Manager will encourage and motivate associates to be successful and focused on Safety, Transparency, Availability, and Quality (STAQ) objectives. A great fit for this role is an individual with 5+ years of Quality Control experience supporting pharmaceutical and manufacturing activities.
Responsibilities:
- Develops, manages, and improves Quality Control processes and procedures to ensure compliance with all applicable laws, regulations, and STAQ Quality standards in support of cGMP standards for pharmaceutical manufacturing (503B).
- Oversees the process for laboratory analysis of raw materials, in-process QC, finished goods release testing, and reserve sample management.
- Participates in internal/external audits and regulatory inspections.
- Supports the stability program including study management, protocol development & evaluation, timely completion of stability tests, data trending, etc.
- Identify and devise ways to improve the operations process to ensure higher-quality processes and products.
- Ensure investigations related to OOS/OOT, unexpected results, adverse trends, or other investigations are performed appropriately and within expected timeframes.
- Manages reserve and QC samples for stability and batch release testing
- Responsible for inspecting the finished goods testing results, comparing it to the requirements, and approving or rejecting final products.
- Assists with all aspects of Quality Systems, such as Change Controls, Investigations, Corrective/Preventive Actions, Validation, APQRs, etc. to resolve quality and compliance issues, including data integrity, in a timely manner.
- Coordinates operations within the internal laboratory to ensure Environmental Monitoring samples are performed, tested, reviewed, and trended appropriately.
- Prepares, reviews, manages, and approves controlled documents (SOPs, protocols, logbooks, reports, etc.) relevant to STAQ QC operations.
- Manages relationships with external laboratories to meet company requirements and turn-around times. Helps to manage relationships with suppliers of components
- Manages, mentors, trains, and coordinates QC staff and/or consultants towards proper execution of SOPs & test methods.
- Manages the budget for the QC department to meet financial objectives.
- Demonstrates a thorough understanding and sound scientific judgment to lead microbiology and chemistry projects, assess analytical outcomes, and direct work actions.
- Other duties as assigned.
Required Skills/Abilities:
- Working knowledge of aseptic/sterile manufacturing techniques.
- Ability to coordinate multiple priorities in a fast-paced environment.
- Strong communication skills with the ability to interact with all levels across the organization.
- Must have a minimum of 5 years of experience with Quality Control managerial experience
- B.S. in Chemistry, Microbiology, or equivalent experience, minimum.
- Should have proficiency/experience with environmental monitoring program for aseptic facility, personnel monitoring, and qualification program for aseptic facility, etc.
- Experience in maintaining cGMP compliance a must.
- Familiarity with 21CFR Part 11/21/211
- Must demonstrate understanding and/or working knowledge of cGMP, FDA, USP, ICH, etc. regulations/guidelines.
- Experience managing teams and projects.
- Must have strong analytical skills
Preferred Skills:
- Ability to coordinate multiple priorities in a fast-paced environment.
- Solid organizational, analytical, and problem-solving skills.
- Strong communication skills with the ability to interact with all levels throughout the organization.
- Demonstrated excellent interpersonal skills and flexibility and successful leadership.
- Attention to detail.
- Proficient in using Microsoft Office.
This position will work closely with Operations and report quality data to department management, as needed
Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.
The application window for this position is anticipated to be open at least 40 days
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