MQA Specialist – Quality Assurance (R-MQA)
Location: Rochester, Michigan
Position Summary: In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
Ensures that manufacturing and packaging operations conform to established company procedures and applicable regulatory requirements by performing daily monitoring of these processes. Performs batch record reviews and batch release according to product acceptance specifications. Evaluates and approves quality investigations and associated corrective and preventative actions (CAPA). The essential duties/competencies for this position include but are not limited to:
- Performs daily monitoring of manufacturing/packaging operations with a focus on right first time
- Performs batch record review and approval based on product acceptance specifications
- Plays an active role in solving compliance errors when detected during these processes
- Enforcement of quality standards and process controls
- Evaluates and approves quality investigations and associated CAPAs; may be involved in critical quality investigations
- Performs customer complaint investigations
- Assists in training of new colleagues
- Assists in internal audits of manufacturing areas/processes; has the ability to perform these audits without assistance
- Communicates with contract customer regarding closure of investigations and batch release status; resolves questions regarding batch record documentation
- Performs assigned work in timely and safe manner conforming to regulatory, company, and compendial requirements
- Must make effective decisions in a timely manner and be focused on execution until completion
- Recognizes problems within scope of job and promptly and clearly communicates them to management
- Recognizes trends, deviations, problems and promptly reports them to management
- Follows directions and demonstrates proper judgment when a deviation occurs
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required – Bachelor of Science Degree required in Chemistry, Pharmacy, Microbiology, or related technical field and greater than 2 years experience in sterile product operations, pharmaceutical technology, or packaging engineering field Desired – Greater than 4 years experience in sterile product operations, pharmaceutical technology, or packaging engineering field
If you possess the required background and are interested in being a member of this growing company, submit your resume and cover letter by mail or apply online:
By Mail MCP Pharmaceuticals LLC HR Department, Job Code SAS 870 Parkdale Road Rochester, Michigan 48307
Apply Online To apply for this position, please Apply Online
About MCP Pharmaceuticals, LLC: MCP Pharmaceuticals is an integrated specialty healthcare company that specializes in sterile injectable products. MCP manufactures and sells brand aseptic injectable pharmaceuticals in hospital and clinical settings and provides contract manufacturing services for global pharmaceutical companies.
MCP’s own product portfolio includes leading diagnostic, women’s health and anesthesia products. All products have a long track record of “gold standard” service and are at or near the front line of treatment in their therapeutic indications. Contract manufactured products include some of the leading global biologic products which involve liquid, lyophilized and suspension presentations.
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